ABSTRACT
OBESITY 250.11 THYROID-CONTAINING DRUG PREPARATIONS INTENDED FOR TREATMENT
OF OBESITY IN HUMANS Drugs Regarded As Misbranded; Specific Requirements For Specific Human Drugs
OBJECTIONS 12.22 FILING OBJECTIONS AND REQUESTS FOR A HEARING ON A REGULATION OR ORDER Initiation Of Proceedings; Formal Evidentiary Public Hearing
OBJECTIONS 12.23 NOTICE OF FILING OF OBJECTIONS Initiation Of Proceedings; Formal Evidentiary Public Hearing
OBJECTIONS 12.24 RULING ON OBJECTIONS AND REQUESTS FOR HEARING Initiation Of Proceedings; Formal Evidentiary Public Hearing
OBJECTIONS 71.30 PROCEDURE FOR FILING OBJECTIONS TO REGULATIONS Administrative Action On Petitions; Color Additive Petitions
OBJECTIONS 171.110 PROCEDURE FOR OBJECTIONS AND HEARINGS Administrative Actions On Applications; Food Additive Petitions
OBJECTIONS 571.110 PROCEDURE FOR OBJECTIONS AND HEARINGS Administrative Actions On Applications; Food Additive Petitions
OBJECTIONS 1316.60 OBJECTIONS; OFFER OF PROOF Administrative Hearings; Administrative Functions, Practices, And Procedures
OBLET 520.1242b LEVAMISOLE HYDROCHLORIDE TABLET OR OBLET (BOLUS) Oral Dosage Form New Animal Drugs
OBLET 520.2260a SULFAMETHAZINE OBLET, TABLET, AND BOLUS Oral Dosage Form New Animal Drugs
OBLIGATION 1004.1 MANUFACTURER’S OBLIGATION TO REPAIR, REPLACE, OR REFUND COST OF ELECTRONIC PRODUCTS Repurchase, Repairs, Or Replacement Of Electronic Products
OBLIGATIONS 26.62 GENERAL OBLIGATIONS Framework Provisions; Mutual Recognition Of Pharmaceutical GMP Reports, Medical Device Quality System Audit Reports
OBLIGATIONS 26.75 SUSPENSION OF RECOGNITION OBLIGATIONS Framework Provisions; Mutual Recognition Of Pharmaceutical GMP Reports, Medical Device Quality System Audit Reports
OBLIGATIONS 312.52 TRANSFER OF OBLIGATIONS TO A CONTRACT RESEARCH ORGANIZATION Investigational New Drug Application
OBLIGATIONS 821.30 TRACKING OBLIGATIONS OF PERSONS OTHER THAN DEVICE MANUFACTURERS: DISTRIBUTOR REQUIREMENTS Medical Device Tracking Requirements
OBSTETRIC 884.2050 OBSTETRIC DATA ANALYZER Obstetrical And Gynecological Monitoring Devices; Obstetrical And Gynecological Devices
OBSTETRIC 884.2225 OBSTETRIC-GYNECOLOGIC ULTRASONIC IMAGER Obstetrical And Gynecological Monitoring Devices; Obstetrical And Gynecological Devices
OBSTETRIC 884.2960 OBSTETRIC ULTRASONIC TRANSDUCER AND ACCESSORIES Obstetrical And Gynecological Monitoring Devices; Obstetrical And Gynecological Devices
OBSTETRIC 884.4400 OBSTETRIC FORCEPS Obstetrical And Gynecological Surgical Devices; Obstetrical And Gynecological Devices
OBSTETRIC 884.4500 OBSTETRIC FETAL DESTRUCTIVE INSTRUMENT Obstetrical And Gynecological Surgical Devices; Obstetrical And Gynecological Devices
OBSTETRIC 884.4520 OBSTETRIC-GYNECOLOGIC GENERAL MANUAL INSTRUMENT Obstetrical And Gynecological Surgical Devices; Obstetrical And Gynecological Devices
OBSTETRIC 884.4530 OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT Obstetrical And Gynecological Surgical Devices; Obstetrical And Gynecological Devices
OBSTETRIC 884.4900 OBSTETRIC TABLE AND ACCESSORIES Obstetrical And Gynecological Surgical Devices; Obstetrical And Gynecological Devices
OBSTETRIC 884.5100 OBSTETRIC ANESTHESIA SET Obstetrical And Gynecological Therapeutic Devices; Obstetrical And Gynecological Devices
OBSTRUCTION 868.5115 DEVICE TO RELIEVE ACUTE UPPER AIRWAY OBSTRUCTION Therapeutic Devices; Anesthesiology Devices
OBTURATOR 868.5650 ESOPHAGEAL OBTURATOR Therapeutic Devices; Anaesthesiology Devices
OCCLUDER 870.1370 CATHETER TIP OCCLUDER
Neurological Therapeutic Devices; Neurological Devices
OCCLUSION 870.2890 VESSEL OCCLUSION TRANSDUCE Cardiovascular Monitoring Devices; Cardiovascular Devices
OCCLUSION 880.5950 UMBILICAL OCCLUSION DEVICE General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices
OCCLUSION 884.5380 CONTRACEPTIVE TUBAL OCCLUSION DEVICE (TOD) AND INTRODUCER Obstetrical And Gynecological Therapeutic Devices; Obstetrical And Gynecological Devices
OCCLUSIVE WOUND DRESSING 878.4020 OCCLUSIVE WOUND DRESSING Surgical Devices; General And Plastic Surgery Devices
OCCULT BLOOD 864.6550 OCCULT BLOOD TEST Manual Hematology Devices; Hematology And Pathology Devices
OCEAN VESSELS 1301.25 REGISTRATION REGARDING OCEAN VESSELS, COMMERCIAL AIRCRAFT, AND CERTAIN OTHER ENTITIES Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
OCTADECYLAMINE 200.11 USE OF OCTADECYLAMINE IN STEAM LINES OF DRUG ESTABLISHMENTS General Provisions; General
OCTAFLUOROCYCLOBUTANE 173.360 OCTAFLUOROCYCLOBUTANE Specific Usage Additives; Secondary Direct Food Additives Permitted In Food For Human Consumption
OCTANE 176.160 CHROMIUM (CR Ill) COMPLEX N-ETHYL-N-HEPTADECYLFLUORO-OCTANE SULFONYL GLYCINE Substances For Use Only As Components Of Paper And Paperboard; Indirect Food Additives
OCULAR 882.1790 OCULAR PLETHYSMOGRAPH Neurological Diagnostic Devices; Neurological Devices
OCULAR 886.1040 OCULAR ESTHESIOMETER Diagnostic Devices; Ophthalmic Devices
OCULAR 886.4360 OCULAR SURGERY IRRIGATION DEVICE Surgical Devices; Ophthalmic Devices
OCULAR 886.4610 OCULAR PRESSURE APPLICATOR Surgical Devices; Ophthalmic Devices
ODORLESS LIGHT PETROLEUM 172.884 ODORLESS LIGHT PETROLEUM HYDROCARBONS Multipurpose Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
ODORLESS LIGHT PETROLEUM 178.3650 ODORLESS LIGHT PETROLEUM HYDROCARBONS Certain Adjuvants And Production Aids; Indirect Food Additives: Adjuvants, Production Aids, And Sanitizers
ODORLESS LIGHT PETROLEUM 573.740 ODORLESS LIGHT PETROLEUM HYDROCARBONS Food Additive Listing; Food Additives Permitted In Feed And Drinking Water Of Animals
OFFER OF PROOF 1316.60 OBJECTIONS; OFFER OF PROOF Administrative Hearings; Administrative Functions, Practices, And Procedures
OFFICE NAT. DRUG CONTROL 1401.2 THE OFFICE OF NATIONAL DRUG CONTROL POLICY - ORGANIZATION AND FUNCTIONS Public Availability Of Information
OFFICER 3.6 PRODUCT JURISDICTION OFFICER Product Jurisdiction
OFFICER, PRESIDING 12.60 PRESIDING OFFICER Presiding Officer; Formal Evidentiary Public Hearing
OFFICER, PRESIDING 12.70 AUTHORITY OF PRESIDING OFFICER Presiding Officer; Formal Evidentiary Public Hearing
OFFICER, PRESIDING 12.75 DISQUALIFICATION OF PRESIDING OFFICER Presiding Officer; Formal Evidentiary Public Hearing
OFFICER, PRESIDING 12.78 UNAVAILABILITY OF PRESIDING OFFICER Presiding Officer; Formal Evidentiary Public Hearing
OFFICER, PRESIDING 12.97 INTERLOCUTORY APPEAL FROM RULING OF PRESIDING OFFICER Hearing Procedures; Formal Evidentiary Public Hearing
OFFICER, PRESIDING 16.42 PRESIDING OFFICER Commissioner And Presiding Officer; Regulatory Hearing Before The Food And Drug Administration
OFFICER, PRESIDING 16.44 COMMUNICATION TO PRESIDING OFFICER AND COMMISSIONER Commissioner And Presiding Officer; Regulatory Hearing Before The Food And Drug Administration
OFFICER, PRESIDING 17.18 INTERLOCUTORY APPEAL FROM RULING OF PRESIDING OFFICER Civil Money Penalties Hearings
OFFICER, PRESIDING 17.19 AUTHORITY OF THE PRESIDING OFFICER Civil Money Penalties Hearings
Administrative Hearings; Administrative Functions, Practices, And Procedures
OFFICERS 5.20 GENERAL REDELEGATIONS OF AUTHORITY FROM THE COMMISSIONER TO OTHER OFFICERS OF THE FDA General Redelegations Of Authority; Delegations Of Authority And Organization
OFFICERS 1316.72 OFFICERS WHO WILL MAKE SEIZURES Seizure, Forfeiture, And Disposition Of Property; Administrative Functions, Practices, And Procedures
OFFICES, PUBLIC INFORMATION 5.1110 FDA PUBLIC INFORMATION OFFICES Organization; Delegations Of Authority And Organization
OFFICIAL COMPENDIA 369.7 WARNINGS REQUIRED BY OFFICIAL COMPENDIA Definitions And Interpretations; Interpretative Statements Re: Warnings On Drugs And Devices For OTC Sale
OFFICIAL NOTICE 12.95 OFFICIAL NOTICE Hearing Procedures; Formal Evidentiary Public Hearing
OFFICIAL RECORDS 5.23 DISCLOSURE OF OFFICIAL RECORDS AND AUTHORIZATION OF TESTIMONY General Redelegations Of Authority; Delegations Of Authority And Organization
OFFICIAL RELEASE 610.2 REQUESTS FOR SAMPLES AND PROTOCOLS; OFFICIAL RELEASE Release Requirements; General Biological Products Standards
OFFICIAL RELEASE 660.6 SAMPLES; PROTOCOLS; OFFICIAL RELEASE Antibody To Hepatitis B Surface Antigen; Additional Standards For Diagnostic Substances For Laboratory Tests
OFFICIAL RELEASE 660.29 SAMPLES; PROTOCOLS; OFFICIAL RELEASE Blood Grouping Reagent; Additional Standards For Diagnostic Substances For Laboratory Tests
OFFICIAL RELEASE 660.46 SAMPLES; PROTOCOLS; OFFICIAL RELEASE Hepatitis B Surface Antigen; Additional Standards For Diagnostic Substances For Laboratory Tests
OFFICIAL TRANSCRIPT 12.98 OFFICIAL TRANSCRIPT Hearing Procedures; Formal Evidentiary Public Hearing
OFFICIAL TRANSCRIPT 1316.63 OFFICIAL TRANSCRIPT; INDEX; CORRECTIONS Administrative Hearings; Administrative Functions, Practices, And Procedures
OFFICIAL, RESPONSIBLE 25.45 RESPONSIBLE AGENCY OFFICIAL Preparation of Environmental Documents; Environmental Impact Considerations
OFFICIALS 5.35 OFFICIALS AUTHORIZED TO MAKE CERTIFICATION UNDER 5 U.S.C. 605(B) FOR ANY PROPOSED AND FINAL RULES General Redelegations Of Authority; Delegations Of Authority And Organization
OFFICIALS, FOREIGN 20.89 COMMUNICATIONS WITH FOREIGN GOVERNMENT OFFICIALS GOVERNMENT Limitations On Exemptions; Public Information
OFFICIALS, LAW ENFORCEMENT 1301.26 EXEMPTION OF LAW ENFORCEMENT OFFICIALS Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
OFFICIALS, LAW ENFORCEMENT 1309.26 EXEMPTION OF LAW ENFORCEMENT OFFICIALS Registration Of Manufacturers, Distributors, Importers And Exporters Of List I Chemicals
OFFICIALS, PUBLIC HEALTH 5.10 DELEGATIONS FROM THE SECRETARY, THE ASSISTANT SECRETARY FOR HEALTH, AND PUBLIC HEALTH SERVICE OFFICIALS Delegations Of Authority To The Commissioner Of Food And Drug; Delegations Of Authority And Organization
OFFICIALS, STATE/LOCAL 20.84 DISCLOSURE TO CONSULTANTS, ADVISORY COMMITTEES, STATE AND GOVERNMENT LOCAL GOVERNMENT OFFICIALS AND OTHER SPECIAL GOVERNMENT
EMPLOYEES Limitations On Exemptions; Public Information
OFFICIALS, STATE/LOCAL 20.88 COMMUNICATIONS WITH STATE AND LOCAL GOVERNMENT OFFICIALS GOVERNMENT Limitations On Exemptions; Public Information
OFFSET 176.130 ANTI-OFFSET SUBSTANCES Substances For Use Only As Components Of Paper And Paperboard; Indirect Food Additives
OHIO 808.85 OHIO Listing Of Specific State And Local Exemptions; Exemption From Federal Preemption Of State & Local Medical Device Requirements
OIL 522.1696c PENICILLIN G PROCAINE IN OIL Implantation Or Injectable Dosage Form New Animal Drugs
OIL 526.1590 NOVOBIOCIN OIL SUSPENSION Intramammary Dosage Forms
OIL 526.1696a PENICILLIN G PROCAINE IN OIL Intramammary Dosage Forms
OIL, CARROT 73.300 CARROT OIL Foods; Listing Of Color Additives Exempt From Certification
OIL, CASTOR 172.876 CASTOR OIL Multipurpose Additives; Food Additives Permitted For Direct Addition To Food For
Certain Adjuvants And Production Aids; Indirect Food Additives: Adjuvants, Production Aids, And Sanitizers
OIL, CASTOR 524.2620 LIQUID CRYSTALLINE TRYPSIN, PERU BALSAM, CASTOR OIL Ophthalmic And Topical Dosage Form New Animal Drugs
OIL, COCONUT 172.816 METHYL GLUCOSIDE-COCONUT OIL ESTER Multipurpose Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
OIL, COCONUT 172.861 COCOA BUTTER SUBSTITUTE FROM COCONUT OIL, PALM KERNEL OIL, OR BOTH OILS Food Additives Permitted For Direct Addition To Food For Human Consumption
OIL, COCONUT 573.660 METHYL GLUCOSIDE-COCONUT OIL ESTER Food Additive Listing; Food Additives Permitted In Feed And Drinking Water Of Animals
OIL, CORN ENDOSPERM 73.315 CORN ENDOSPERM OIL Foods; Listing Of Color Additives Exempt From Certification
OIL, EDIBLE 102.37 MIXTURES OF EDIBLE FAT OR OIL AND OLIVE OIL Requirements For Specific Nonstandardized Foods; Common Or Usual Name For Nonstandardized Foods
OIL, FISH 186.1551 HYDROGENATED FISH OIL Listing Of Specific Substances Affirmed As GRAS; Indirect Food Substances Affirmed As Generally Recognized As Safe
OIL, MENHADEN 184.1472 MENHADEN OIL Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
OIL, MINERAL 172.878 WHITE MINERAL OIL Multipurpose Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
OIL, MINERAL 178.3620 MINERAL OIL Certain Adjuvants And Production Aids; Indirect Food Additives: Adjuvants, Production Aids, And Sanitizers
OIL, MINERAL 201.302 NOTICE TO MANUFACTURERS, PACKERS, AND DISTRIBUTORS OF DRUGS FOR INTERNAL USE WHICH CONTAIN MINERAL OIL Specific Labeling Requirements For Specific Drug Products; Labeling
OIL, MINERAL 573.680 MINERAL OIL Food Additive Listing; Food Additives Permitted In Feed And Drinking Water Of Animals
OIL, OLIVE 102.37 MIXTURES OF EDIBLE FAT OR OIL AND OLIVE OIL Requirements For Specific Nonstandardized Foods; Common Or Usual Name For Nonstandardized Foods
OIL, PALM KERNEL 172.861 COCOA BUTTER SUBSTITUTE FROM COCONUT OIL, PALM KERNEL OIL, OR BOTH OILS Food Additives Permitted For Direct Addition To Food For Human Consumption
OIL, RAPESEED 184.1555 RAPESEED OIL Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
OIL OF RUE 184.1699 OIL OF RUE Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
OIL, SHEANUT 184.1702 SHEANUT OIL Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
OIL, SOYBEAN 172.723 EPOXIDIZED SOYBEAN OIL Food Additive Permitted For Direct Addition To Food For Human Consumption
OIL, SOYBEAN 526.1696b PENICILLIN G PROCAINE-DIHYDROSTREPTOMYCIN IN SOYBEAN OIL FOR INTRAMAMMARY INFUSION (DRY COWS) Intramammary Dosage Forms
OIL, SPERM 173.275 HYDROGENATED SPERM OIL Solvents, Lubricants, Release Agents And Related Substances; Secondary Direct Food Additives Permitted In Food For Human Consumption
OIL, TALL 172.862 OLEIC ACID DERIVED FROM TALL OIL FATTY ACIDS Multipurpose Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
OIL, TALL 186.1557 TALL OIL Listing Of Specific Substances Affirmed As GRAS; Indirect Food Substances Affirmed As Generally Recognized As Safe
OIL, VEGETABLE 180.30 BROMINATED VEGETABLE OIL Specific Requirements For Certain Food Additives; Food Additives Permitted In Food Or In Contact With Food On Interim Basis Pending Study
OIL, WINTERGREEN 201.303 LABELING OF DRUG PREPARATIONS CONTAINING SIGNIFICANT PROPORTIONS OF WINTERGREEN OIL
BOTH OILS Food Additives Permitted For Direct Addition To Food For Human Consumption
OILS, DRYING 181.26 DRYING OILS AS COMPONENTS OF FINISHED RESINS Specific Prior-sanctioned Food Ingredients; Prior-sanctioned Food Ingredients
OILS, EDIBLE 172.225 METHYL ESTERS OF FATTY ACIDS PRODUCED FROM EDIBLE FATS AND OILS Coatings, Films And Related Substances; Food Additives Permitted For Direct Addition To Food For Human Consumption
OILS, EDIBLE 582.4101 DIACETYL TARTARIC ACID ESTERS OF MONO-AND DIGLYCERIDES OF EDIBLE FATS OR OILS, OR EDIBLE FAT-FORMING FATTY ACIDS Emulsifying Agents; Substances Generally Recognized As Safe
OILS, EDIBLE 582.4505 MONO-AND DIGLYCERIDES OF EDIBLE FATS OR OILS, OR EDIBLE FATFORMING ACIDS Emulsifying Agents; Substances Generally Recognized As Safe
OILS, EDIBLE 582.4521 MONOSODIUM PHOSPHATE DERIVATIVES OF MONO-AND DIGLYCERIDES OF EDIBLE FATS OR OILS, OR EDIBLE FAT-FORMING FATTY ACIDS Emulsifying Agents; Substances Generally Recognized As Safe
OILS, ESSENTIAL 182.20 ESSENTIAL OILS, OLEORESINS (SOLVENT-FREE), AND NATURAL EXTRACTIVES (INCLUDING DISTILLATES) General Provisions; Substances Generally Recognized As Safe
OILS, ESSENTIAL 182.50 CERTAIN OTHER SPICES, SEASONINGS, ESSENTIAL OILS, OLEORESINS, AND NATURAL EXTRACTS General Provisions; Substances Generally Recognized As Safe
OILS, ESSENTIAL 582.20 ESSENTIAL OILS, OLEORESINS (SOLVENT-FREE),AND NATURAL EXTRACTIVES INCLUDING DISTILLATES) General Provisions; Substances Generally Recognized As Safe
OILS, ESSENTIAL 582.50 CERTAIN OTHER SPICES, SEASONINGS, ESSENTIAL OILS, OLEORESINS, AND NATURAL EXTRACTS General Provisions; Substances Generally Recognized As Safe
OINTMENT 524.154 BACITRACIN OR BACITRACIN ZINC-NEOMYCIN POLYMIXIN-B SULFATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.155 BACITRACIN ZINC-POLYMYXIN B SULFATE, NEOMYCIN SULFATEHYDROCORTISONE OR HYDROCORTISONE ACETATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.390a CHLORAMPHENICOL OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.390d CHLORAMPHENICOL-PREDNISOLONE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.402 CHLORHEXIDINE DIACETATE OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.575 CYCLOSPORINE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1044c GENTAMICIN OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1044d GENTAMICIN SULFATE, BETAMETHASONE VALERATE OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1044g GENTAMICIN SULFATE, BETAMETHASONE VALERATE, CLOTRIMASOLE OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1200a KANAMYCIN OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1465 MUPIROCIN OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1484a NEOMYCIN SULFATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1484c NEOMYCIN SULFATE, ISOFLUPREDONE ACETATE, TETRACAINE HYDROCHLORIDE OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1484d NEOMYCIN SULFATE, HYDROCORTISONE ACETATE, TETRACAINE HYDROCHLORIDE EAR OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1484i NEOMYCIN SULFATE, HYDROCORTISONE ACETATE, STERILE OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1580b NITROFURAZONE OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1580e NITROFURAZONE OINTMENT WITH BUTACAINE SULFATE Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1600a NYSTATIN, NEOMYCIN, THIOSTREPTON, AND TRIAMCINOLONE ACETONIDE
OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1662 OXYTETRACYCLINE HYDROCHLORIDE, POLYMYXIN B SULFATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1880 PREDNISOLONE-NEOMYCIN SULFATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OINTMENT 524.1883 PREDNISOLONE SODIUM PHOSPHATE-NEOMYCIN SULFATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OLD ASIAGO CHEESE 133.104 ASIAGO OLD CHEESE Requirements For Specific Standardized Cheese And Related Products; Cheeses And Related Cheese Products
OLD DEVICES 860.84 CLASSIFICATION PROCEDURES FOR “OLD DEVICES” Classification; Medical Device Classification Procedures
OLEANDOMYCIN 556.480 OLEANDOMYCIN Specific Tolerances For Residues Of New Animal Drugs; Tolerances For Residues Of New Animal Drugs In Food
OLEANDOMYCIN 558.435 OLEANDOMYCIN Specific New Animal Drugs For Use In Animal Feeds; New Animal Drugs For Use In Animal Feeds
OLEATE, BUTYL 172.270 SULFATED BUTYL OLEATE Food Additives Permitted For Direct Addition To Food For Human Consumption
OLEATE, SODIUM 186.1770 SODIUM OLEATE Listing Of Specific Substances Affirmed As GRAS; Indirect Food Substances Affirmed As Generally Recognized As Safe
OLEATE SODIUM 522.1610 OLEATE SODIUM SOLUTION Implantation Or Injectable Dosage Form New Animal Drugs
OLEFIN 177.1520 OLEFIN POLYMERS Substances For Use As Basic Components Of Single And Repeated Use Food Contact Surfaces; Indirect Food Additives: Polymers
OLEIC ACID 172.862 OLEIC ACID DERIVED FROM TALL OIL FATTY ACIDS Multipurpose Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
OLEORESIN, PAPRIKA 73.345 PAPRIKA OLEORESIN Foods; Listing Of Color Additives Exempt From Certification
OLEORESIN, TUMERIC 73.615 TUMERIC OLEORESIN Foods; Listing Of Color Additives Exempt From Certification
OLEORESINS 182.20 ESSENTIAL OILS, OLEORESINS (SOLVENT-FREE), AND NATURAL EXTRACTIVES (INCLUDING DISTILLATES) General Provisions; Substances Generally Recognized As Safe
OLEORESINS 182.50 CERTAIN OTHER SPICES, SEASONINGS, ESSENTIAL OILS, OLEORESINS, AND NATURAL EXTRACTS General Provisions; Substances Generally Recognized As Safe
OLEORESINS 582.20 ESSENTIAL OILS, OLEORESINS (SOLVENT-FREE), AND NATURAL EXTRACTIVES (INCLUDING DISTILLATES) General Provisions; Substances Generally Recognized As Safe
OLEORESINS 582.50 CERTAIN OTHER SPICES, SEASONINGS, ESSENTIAL OILS, OLEORESINS, AND NATURAL EXTRACTS General Provisions; Substances Generally Recognized As Safe
OLESTRA 172.867 OLESTRA Food Additives Permitted For Direct Addition To Food For Human Consumption
OLIVE OIL 102.37 MIXTURES OF EDIBLE FAT OR OIL AND OLIVE OIL Requirements For Specific Nonstandardized Foods; Common Or Usual Name For Nonstandardized Foods
OLYMPIA OYSTERS 161.136 OLYMPIA OYSTERS Requirements For Specific Standardized Fish And Shellfish; Fish And Shellfish
OMEPRAZOLE 520.1615 OMEPRAZOLE Oral Dosage Form New Animal Drugs
ON-LINE 870.4330 CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS MONITOR Cardiovascular Surgical Devices; Cardiovascular Devices
ONCOMETER 862.2720 PLASMA ONCOMETER FOR CLINICAL USE Clinical Laboratory Instruments; Clinical Chemistry And Clinical Toxicology Devices
ONCOMETRY 862.1530 PLASMA ONCOMETRY TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices
ONDCP 1401.2 THE OFFICE OF NATIONAL DRUG CONTROL POLICY - ORGANIZATION AND FUNCTIONS Public Availability Of Information
ONDCP 1402.3 INFORMATION IN THE CUSTODY OF ONDCP
Governmentwide Debarment And Suspension And Requirements For Drug-Free Workplace (Grants)
ONION RINGS 102.39 ONION RINGS MADE FROM DICED ONION Requirements For Specific Nonstandardized Foods; Common Or Usual Name For Nonstandardized Foods
OPEN SYSTEMS 11.30 CONTROLS FOR OPEN SYSTEMS Electronic Records; Electronic Signatures
OPERATING HEADLAMP 886.4335 OPERATING HEADLAMP Surgical Devices; Ophthalmic Devices
OPERATING LIGHT 872.4630 DENTAL OPERATING LIGHT Surgical Devices; Dental Devices
OPERATING PROCEDURES 58.81 STANDARD OPERATING PROCEDURES Testing Facilities Operation; Good Laboratory Practice For Nonclinical Laboratory Studies
OPERATING PROCEDURES 120.6 SANITATION STANDARD OPERATING PROCEDURES Hazard Analysis And Critical Control Point (HACCP) Systems
OPERATING PROCEDURES 606.100 STANDARD OPERATING PROCEDURES Production And Process Controls; Current Good Manufacturing Practice For Blood And Blood Components
OPERATING ROOM 878.5070 AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING ROOM Therapeutic Devices; General And Plastic Surgery Devices
OPERATING TABLE/CHAIR 878.4950 MANUAL OPERATING TABLE AND ACCESSORIES AND MANUAL OPERATING CHAIR AND ACCESSORIES Surgical Devices; General And Plastic Surgery Devices
OPERATING TABLES/CHAIRS 878.4960 OPERATING TABLES AND ACCESSORIES AND OPERATING CHAIRS AND ACCESSORIES Surgical Devices; Genera[ And Plastic Surgery Devices
OPERATION 58.49 LABORATORY OPERATION AREAS Facilities; Good Laboratory Practice For Nonclinical Laboratory Studies
OPERATIONAL PERIOD 26.11 START OF OPERATIONAL PERIOD Specific Sector Provisions For Pharmaceutical GMPs; Mutual Recognition Of Pharmaceutical GMP Reports, Medical Device Quality System Audit Reports
OPERATIONAL PERIOD 26.40 START OF THE OPERATIONAL PERIOD Specific Sector Provisions For Medical Devices; Mutual Recognition Of Pharmaceutical GMP Reports, Medical Device Quality System Audit Reports
OPERATIONS 56.108 IRB FUNCTIONS & OPERATIONS IRB Functions And Operations; Institutional Review Boards
OPERATIONS 113.87 OPERATIONS IN THE THERMAL PROCESSING ROOM Production And Process Controls; Thermally Processed Low-acid Foods Packaged In Hermetically Sealed Containers
OPERATIONS 211.130 PACKAGING AND LABELING OPERATIONS Packaging And Labeling Control; Current Good Manufacturing Practice For Finished Pharmaceuticals
OPERATIONS, SANITARY 110.35 SANITARY OPERATIONS Buildings And Facilities; Current Good Manufacturing Practice In Manufacturing, Packing, Or Holding Human Food
OPERATIONS, SANITARY 129.37 SANITARY OPERATIONS Buildings And Facilities; Processing And Bottling Of Bottled Drinking Water
OPERATIVE UNIT, DENTAL 872.6640 DENTAL OPERATIVE UNIT AND ACCESSORIES Miscellaneous Devices; Dental Devices
OPHTHALMIC 510.410 CORTICOSTEROIDS FOR ORAL, INJECTABLE, AND OPHTHALMIC USE IN ANIMALS; WARNINGS AND LABELING REQUIREMENTS Requirements For Specific New Animal Drugs; New Animal Drugs
OPHTHALMIC 524.154 BACITRACIN OR BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMIXIN B SULFATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.155 BACITRACIN ZINC-POLYMIXIN B SULFATE-NEOMYCIN SULFATEHYDROCORTISONE OR HYDROCORTISONE ACETATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.390 CHLORAMPHENICOL OPHTHALMIC AND TOPICAL DOSAGE FORMS Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.575 CYCLOSPORINE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.660 DIMETHYL SULFOXIDE OPHTHALMIC AND TOPICAL DOSAGE FORMS Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.960 FLUMETHASONE, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE OPHTHALMIC SOLUTIONS Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.981 FLUOCINOLONE ACETONIDE OPHTHALMIC AND TOPICAL DOSAGE FORMS
Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.1044c GENTAMICIN OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drug
OPHTHALMIC 524.1200 KANAMYCIN OPHTHALMIC AND TOPICAL DOSAGE FORMS Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.1200b KANAMYCIN OPHTHALMIC AQUEOUS SOLUTION Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.1484 NEOMYCIN SULFATE OPHTHALMIC AND TOPICAL DOSAGE FORMS Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.1484e NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OPHTHALMIC SOLUTION Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.1580 NITROFURAZONE OPHTHALMIC AND TOPICAL DOSAGE FORMS Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.1600 NYSTATIN OPHTHALMIC AND TOPICAL DOSAGE FORMS Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.1600b NYSTATIN, NEOMYCIN, THIOSTREPTON, AND TRIAMCINOLONE ACETONIDE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.1662 OXYTETRACYCLINE HYDROCHLORIDE OPHTHALMIC AND TOPICAL DOSAGE FORMS Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.1662b OXYTETRACYCLINE HYDROCHLORIDE, POLYMYXIN B SULFATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.1880 PREDNISOLONE-NEOMYCIN SULFATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.1881 PREDNISOLONE ACETATE OPHTHALMIC AND TOPICAL DOSAGE FORMS Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.1883 PREDNISOLONE SODIUM PHOSPHATE-NEOMYCIN SULFATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 524.1982 PROPARACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION Ophthalmic And Topical Dosage Form New Animal Drugs
OPHTHALMIC 886.1120 OPHTHALMIC CAMERA Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.1140 OPHTHALMIC CHAIR Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.1405 OPHTHALMIC TRIAL LENS SET Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.1410 OPHTHALMIC TRIAL LENS CLIP Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.1415 OPHTHALMIC TRIAL LENS FRAME Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.1420 OPHTHALMIC LENS GAUGE Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.1430 OPHTHALMIC CONTACT LENS RADIUS MEASURING DEVICE Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.1640 OPHTHALMIC PREAMPLIFIER Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.1650 OPHTHALMIC BAR PRISM Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.1655 OPHTHALMIC FRESNEL PRISM Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.1665 OPHTHALMIC ROTARY PRISM Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.1670 OPHTHALMIC ISOTOPE UPTAKE PROBE Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.1680 OPHTHALMIC PROJECTOR Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.1760 OPHTHALMIC REFRACTOMETER Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.1860 OPHTHALMIC INSTRUMENT STAND Diagnostic Devices; Ophthalmic Devices
OPHTHALMIC 886.3100 OPHTHALMIC TANTALUM CLIP Prosthetic Devices; Ophthalmic Devices
OPHTHALMIC 886.3130 OPHTHALMIC CONFORMER Prosthetic Devices; Ophthalmic Devices
OPHTHALMIC 886.4230 OPHTHALMIC KNIFE TEST DRUM Surgical Devices; Ophthalmic Devices
OPHTHALMIC 886.4250 OPHTHALMIC ELECTROLYSIS UNIT
Surgical Devices; Ophthalmic Devices
OPHTHALMIC 886.4570 OPHTHALMIC SURGICAL MARKER Surgical Devices; Ophthalmic Devices
OPHTHALMIC 886.4690 OPHTHALMIC PHOTOCOAGULATOR Surgical Devices; Ophthalmic Devices
OPHTHALMIC 886.4750 OPHTHALMIC EYE SHIELD Surgical Devices; Ophthalmic Devices
OPHTHALMIC 886.4770 OPHTHALMIC OPERATING SPECTACLES (LOUPES) Surgical Devices; Ophthalmic Devices
OPHTHALMIC 886.4790 OPHTHALMIC SPONGE Surgical Devices; Ophthalmic Devices
OPHTHALMIC 886.4855 OPHTHALMIC INSTRUMENT TABLE Surgical Devices; Ophthalmic Devices
OPHTHALMIC 886.5100 OPHTHALMIC BETA RADIATION SOURCE Therapeutic Devices; Ophthalmic Devices
OPHTHALMIC 886.5800 OPHTHALMIC BAR READER Therapeutic Devices; Ophthalmic Devices
OPHTHALMIC 886.5810 OPHTHALMIC PRISM READER Therapeutic Devices; Ophthalmic Devices
OPHTHALMIC ASTRINGENT 349.10 OPHTHALMIC ASTRINGENT Active Ingredients; Ophthalmic Drug Products For Over-the-counter Human Use
OPHTHALMIC ASTRINGENT 349.55 LABELING OF OPHTHALMIC ASTRINGENT DRUG PRODUCTS Labeling; Ophthalmic Drug Products For Over-the-counter Human Use
OPHTHALMIC DEMULCENT 349.60 LABELING OF OPHTHALMIC DEMULCENT DRUG PRODUCTS Labeling; Ophthalmic Drug Products For Over-the-counter Human Use
OPHTHALMIC DEMULCENTS 349.12 OPHTHALMIC DEMULCENTS Active Ingredients; Ophthalmic Drug Products For Over-the-counter Human Use
OPHTHALMIC DRUG 349.50 LABELING OF OPHTHALMIC DRUG PRODUCTS Labeling; Ophthalmic Drug Products For Over-the-counter Human Use
OPHTHALMIC EMOLLIENT 349.65 LABELING OF OPHTHALMIC EMOLLIENT DRUG PRODUCTS Labeling; Ophthalmic Drug Products For Over-the-counter Human Use
OPHTHALMIC EMOLLIENTS 349.14 OPHTHALMIC EMOLLIENTS Active Ingredients; Ophthalmic Drug Products For Over-the-counter Human Use
OPHTHALMIC HYPERTONICITY 349.16 OPHTHALMIC HYPERTONICITY AGENT Active Ingredients; Ophthalmic Drug Products For Over-the-counter Human Use
OPHTHALMIC HYPERTONICITY 349.70 LABELING OF OPHTHALMIC HYPERTONICITY DRUG PRODUCTS Labeling; Ophthalmic Drug Products For Over-the-counter Human Use
OPHTHALMIC PREPARATIONS 200.50 OPHTHALMIC PREPARATIONS AND DISPENSERS Requirements For Specific Classes Of Drugs; General
OPHTHALMIC 349.75 LABELING OF OPHTHALMIC VASOCONSTRICTOR DRUG PRODUCTS VASOCONSTRICTOR Labeling; Ophthalmic Drug Products For Over-the-counter Human Use
OPHTHALMIC 349.18 OPHTHALMIC VASOCONSTRICTORS VASOCONSTRICTORS Active Ingredients; Ophthalmic Drug Products For Over-the-counter Human Use
OPHTHALMOSCOPE 886.1570 OPHTHALMOSCOPE Diagnostic Devices; Ophthalmic Devices
OPIATE 862.3650 OPIATE TEST SYSTEM Clinical Toxicology Test Systems; Clinical Chemistry And Clinical Toxicology Devices
OPINION LETTERS 170.6 OPINION LETTERS ON FOOD ADDITIVE STATUS General Provisions; Food Additives
OPINION LETTERS 570.6 OPINION LETTERS ON FOOD ADDITIVE STATUS General Provisions; Food Additives
OPINIONS 310.100 NEW DRUG STATUS OPINIONS; STATEMENT OF POLICY Specific Administrative Rulings And Decisions; New Drugs
OPINIONS, ADVISORY 10.85 ADVISORY OPINIONS General Administrative Procedures; Administrative Practices And Procedures
OPINIONS, ADVISORY 12.83 ADVISORY OPINIONS Hearing Procedures; Formal Evidentiary Public Hearing
OPINIONS, ADVISORY 808.5 ADVISORY OPINIONS General Provisions; Exemption From Federal Preemption Of State & Local Medical Device Requirements
OPPORTUNITIES 7.87 RECORDS RELATED TO OPPORTUNITIES FOR PRESENTATION OF VIEWS CONDUCTED BEFORE REPORT OF CRIMINAL VIOLATION Criminal Violations; Enforcement Policy
OPPORTUNITY 5.202 ISSUANCE OF NOTICES OF OPPORTUNITY FOR A HEARING ON PROPOSALS FOR DENIAL OF APPROVAL OF APPLICATIONS FOR LICENSES, SUSPENSION OF LICENSES, OR REVOCATION OF LICENSES AND CERTAIN NOTICES Biologics; Redelegations Of Authority; Delegations Of Authority And Organization
OPPORTUNITY 7.84 OPPORTUNITY FOR PRESENTATION OF VIEWS BEFORE REPORT OF CRIMINAL VIOLATION
FOR A FORMAL EVIDENTIARY PUBLIC HEARING General Administrative Procedures; Administrative Practices And Procedures
OPPORTUNITY 58.204 NOTICE OF AND OPPORTUNITY FOR HEARING ON PROPOSED DISQUALIFICATION Disqualification Of Testing Facilities; Good Laboratory Practice For Nonclinical Laboratory Studies
OPPORTUNITY 310.6 APPLICABILITY OF “NEW DRUG” OR SAFETY/EFFECTIVENESS FINDINGS IN DRUG EFFICACY STUDY IMPLEMENTATION NOTICES AND NOTICES OF OPPORTUNITY FOR HEARING TO IDENTICAL, RELATED, AND SIMILAR DRUG PRODUCTS General Provisions; New Drugs
OPPORTUNITY 314.200 NOTICE OF OPPORTUNITY FOR HEARING; NOTICE OF PARTICIPATION AND REQUEST FOR HEARING; GRANT OR DENIAL OF HEARING Hearing Procedures For New Drugs; Applications For FDA Approval To Market A New Drug
OPPORTUNITY 514.200 CONTENTS OF NOTICE OF OPPORTUNITY FOR A HEARING Hearing Procedures; New Animal Drug Applications
OPPORTUNITY 515.30 CONTENTS OF NOTICE OF OPPORTUNITY FOR A HEARING Hearing Procedures; Medicated Feed Mill License
OPPORTUNITY 1404.313 OPPORTUNITY TO CONTEST PROPOSED DEBARMENT Debarment; Governmentwide Debarment And Suspension And Requirements For Drug-Free Workplace (Grants)
OPPORTUNITY 1404.412 OPPORTUNITY TO CONTEST PROPOSED SUSPENSION Suspension; Governmentwide Debarment And Suspension And Requirements For Drug-Free Workplace (Grants)
OPTICAL 886.5915 OPTICAL VISION AID Therapeutic Devices; Ophthalmic Devices
OPTOKINETIC 886.1200 OPTOKINETIC DRUM Diagnostic Devices; Ophthalmic Devices
ORAL 520.45 ALBENDAZOLE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.82 AMINOPROPAZINE FUMARATE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.88 AMOXICILLIN ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.90 AMPICILLIN ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.100 AMPROLIUM ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.154 BACITRACIN ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.300 CAMBENDAZOLE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.315 CEFADROXIL POWDER FOR ORAL SUSPENSION Oral Dosage Form New Animal Drugs
ORAL 520.390 CHLORAMPHENICOL ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.445 CHLORTETRACYCLINE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.530 CYTHIOATE ORAL LIQUID Oral Dosage Form New Animal Drugs
ORAL 520.540 DEXAMETHASONE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.563 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM ORAL SOLUTION Oral Dosage Form New Animal Drugs
ORAL 520.620 DIETHYLCARBAMAZINE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.622 DIETHYLCARBAMAZINE CITRATE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.763 DITHIAZANINE IODIDE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.813 ENROFLOXACIN ORAL SOLUTION Oral Dosage Form New Animal Drugs
ORAL 520.903 FEBANTEL ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.905 FENBENDAZOLE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.970 FLUNIXIN ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.1010 FUROSEMIDE ORAL DOSAGE FORMS
Oral Dosage Form New Animal Drugs
ORAL 520.1130 HETACILLIN ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.1182 IRON DEXTRAN ORAL SUSPENSION Oral Dosage Form New Animal Drugs
ORAL 520.1242 LEVAMISOLE HYDROCHLORIDE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.1263 LINCOMYCIN HYDROCHLORIDE MONOHYDRATE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.1320 MEBENDAZOLE ORAL Oral Dosage Form New Animal Drugs
ORAL 520.1326 MEBENDAZOLE AND TRICHLORFON ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.1448 MONENSIN ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.1450 MORANTEL TARTRATE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.1485 NEOMYCIN SULFATE ORAL SOLUTION Oral Dosage Form New Animal Drugs
ORAL 520.1696 PENICILLIN ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.1720 PHENYLBUTAZONE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.1802 PIPERAZINE-CARBON DISULFIDE COMPLEX ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.2122 SPECTINOMYCIN DIHYDROCHLORIDE ORAL SOLUTION Oral Dosage Form New Animal Drugs
ORAL 520.2123 SPECTINOMYCIN DIHYDROCHLORIDE PENTAHYDRATE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.2150 STANOZOLOL ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.2158 STREPTOMYCIN/DIHYDROSTREPTOMYCIN ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.2160 STYRYLPYRIDINIUM, DIETHYLCARBAMAZINE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.2200 SULFACHLORPYRIDAZINE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.2220 SULFADIMETHOXINE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.2260 SULFAMETHAZINE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.2261 SULFAMETHAZINE SODIUM ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.2325 SULFAQUINOXALINE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.2345 TETRACYCLINE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.2380 THIABENDAZOLE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.2380b THIABENDAZOLE DRENCH OR ORAL PASTE Oral Dosage Form New Animal Drugs
ORAL 520.2473 TIOXIDAZOLE ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.2482 TRIAMCINOLONE ACETONIDE ORAL POWDER Oral Dosage Form New Animal Drugs
ORAL 520.2520 TRICHLORFON ORAL DOSAGE FORMS Oral Dosage Form New Animal Drugs
ORAL 520.2611 TRIMETHOPRIM AND SULFADIAZINE ORAL PASTE Oral Dosage Form New Animal Drugs
ORAL 520.2612 TRIMETHOPRIM AND SULFADIAZINE ORAL SUSPENSION Oral Dosage Form New Animal Drugs
ORAL ADMINISTRATION 310.537 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR ORAL ADMINISTRATION FOR THE TREATMENT OF FEVER BLISTERS AND COLD SORES Requirements For Specific New Drugs Or Devices; New Drugs
ORAL CAVITY 872.6030 ORAL CAVITY ABRASIVE POLISHING AGENT Miscellaneous Devices; Dental Devices
ORAL CONTRACEPTIVES 310.501 PATIENT PACKAGE INSERTS FOR ORAL CONTRACEPTIVES Requirements For Specific New Drugs Or Devices; New Drugs
DOSAGE FORMS; REQUIRED WARNING Specific Labeling Requirements For Specific Drug Products; Labeling
ORAL DIGOXIN 310.500 DIGOXIN PRODUCTS FOR ORAL USE; CONDITIONS FOR MARKETING Requirements For Specific New Drugs Or Devices; New Drugs
ORAL DISCUSSIONS 20.104 SUMMARIES OF ORAL DISCUSSIONS Availability Of Specific Categories Of Records; Public Information
ORAL DOSAGE IMPRINTING 330.3 IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS Over-the-counter Human Drugs Generally Recognized As Safe And Effective & Not Misbranded
ORAL HEARINGS 12.90 CONDUCT AT ORAL HEARINGS OR CONFERENCES Hearing Procedures; Formal Evidentiary Public Hearing
ORAL HYGIENE 872.6650 MASSAGING PICK OR TIP OR ORAL HYGIENE Miscellaneous Devices; Dental Devices
ORAL HYPOGLYCEMIC DRUGS 310.517 LABELING FOR ORAL HYPOGLYCEMIC DRUGS OF THE SULFONYLUREA CLASS Requirements For Specific New Drugs Or Devices; New Drugs
ORAL INGESTION 201.306 POTASSIUM SALT PREPARATIONS INTENDED FOR ORAL INGESTION BY MAN Specific Labeling Requirements For Specific Drug Products; Labeling
ORAL INGESTION 328.50 PRINCIPAL DISPLAY PANEL OF ALL OTC DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL Over-the-counter Drug Products Intended For Oral Ingestion That Contain Alcohol
ORAL INHALATION 200.51 AQUEOUS-BASED DRUG PRODUCTS FOR ORAL INHALATION Requirements For Specific Classes Of Drugs; General
ORAL INSECT REPELLANTS 310.529 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR ORAL USE AS INSECT REPELLENTS Requirements For Specific New Drugs Or Devices; New Drugs
ORAL IRRIGATION 872.6510 ORAL IRRIGATION UNIT Miscellaneous Devices; Dental Devices
ORAL TESTIMONY 12.87 PURPOSE; ORAL AND WRITTEN TESTIMONY; BURDEN OF PROOF Hearing Procedures; Formal Evidentiary Public Hearing
ORAL WOUND HEALING 310.534 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR HUMAN USE AS ORAL WOUND HEALING AGENTS Requirements For Specific New Drugs Or Devices; New Drugs
ORANGE 1, VAT 73.3112 C.I. VAT ORANGE 1 Medical Devices; Listing Of Color Additives Exempt From Certification
ORANGE B 74.250 ORANGE B Foods; Listing Of Color Additives Subject To Certification
ORANGE JUICE 146.135 ORANGE JUICE Requirements For Specific Standardized Canned Fruit Juices And Beverages; Canned Fruit Juices
ORANGE JUICE 146.137 FROZEN ORANGE JUICE Requirements For Specific Standardized Canned Fruit Juices And Beverages; Canned Fruit Juices
ORANGE JUICE 146.140 PASTEURIZED ORANGE JUICE Requirements For Specific Standardized Canned Fruit Juices And Beverages; Canned Fruit Juices
ORANGE JUICE 146.141 CANNED ORANGE JUICE Requirements For Specific Standardized Canned Fruit Juices And Beverages; Canned Fruit Juices
ORANGE JUICE 146.145 ORANGE JUICE FROM CONCENTRATE Requirements For Specific Standardized Canned Fruit Juices And Beverages; Canned Fruit Juices
ORANGE JUICE 146.146 FROZEN CONCENTRATED ORANGE JUICE Requirements For Specific Standardized Canned Fruit Juices And Beverages; Canned Fruit Juices
ORANGE JUICE 146.148 REDUCED ACID FROZEN CONCENTRATED ORANGE JUICE Requirements For Specific Standardized Canned Fruit Juices And Beverages; Canned Fruit Juices
ORANGE JUICE 146.150 CANNED CONCENTRATED ORANGE JUICE Requirements For Specific Standardized Canned Fruit Juices And Beverages; Canned Fruit Juices
ORANGE JUICE 146.151 ORANGE JUICE FOR MANUFACTURING Requirements For Specific Standardized Canned Fruit Juices And Beverages; Canned Fruit Juices
ORANGE JUICE 146.152 ORANGE JUICE WITH PRESERVATIVE Requirements For Specific Standardized Canned Fruit Juices And Beverages; Canned Fruit Juices
ORANGE JUICE 146.153 CONCENTRATED ORANGE JUICE FOR MANUFACTURING Requirements For Specific Standardized Canned Fruit Juices And Beverages;
Requirements For Specific Standardized Canned Fruit Juices And Beverages; Canned Fruit Juices
ORANGE NO. 4 74.1254 D&C ORANGE NO. 4 Drugs; Listing Of Color Additives Subject To Certification
ORANGE NO. 4 74.2254 D&C ORANGE NO. 4 Cosmetics; Listing Of Color Additives Subject To Certification
ORANGE NO. 4 82.1254 D&C ORANGE NO. 4 Drugs And Cosmetics; Listing Of Certified Provisionally Listed Colors And Specifications
ORANGE NO. 5 74.1255 D&C ORANGE NO. 5 Drugs; Listing Of Color Additives Subject To Certification
ORANGE NO. 5 74.2255 D&C ORANGE NO. 5 Cosmetics; Listing Of Color Additives Subject To Certification
ORANGE NO. 5 82.1255 D&C ORANGE NO. 5 Drugs And Cosmetics; Listing Of Certified Provisionally Listed Colors And Specifications
ORANGE NO. 10 74.1260 D&C ORANGE NO. 10 Drugs; Listing Of Color Additives Subject To Certification
ORANGE NO. 10 74.2260 D&C ORANGE NO. 10 Cosmetics; Listing Of Color Additives Subject To Certification
ORANGE NO. 10 82.1260 D&C ORANGE NO. 10 Drugs And Cosmetics; Listing Of Certified Provisionally Listed Colors And Specifications
ORANGE NO. 11 74.1261 D&C ORANGE NO. 11 Drugs; Listing Of Color Additives Subject To Certification
ORANGE NO. 11 74.2261 D&C ORANGE NO. 11 Cosmetics; Listing Of Color Additives Subject To Certification
ORANGE NO. 11 82.1261 D&C ORANGE NO. 11 Drugs And Cosmetics; Listing Of Certified Provisionally Listed Colors And Specifications
ORBIFLOXACIN 520.1616 ORBIFLOXACIN PASTE Oral Dosage Form New Animal Drugs
ORBITAL IMPLANT 886.3340 EXTRAOCULAR ORBITAL IMPLANT Prosthetic Devices; Ophthalmic Devices
ORDER 12.21 INITIATION OF A HEARING INVOLVING THE ISSUANCE, AMENDMENT, OR REVOCATION OF AN ORDER Initiation Of Proceedings; Formal Evidentiary Public Hearing
ORDER 12.22 FILING OBJECTIONS AND REQUESTS FOR A HEARING ON A REGULATION OR ORDER Initiation Of Proceedings; Formal Evidentiary Public Hearing
ORDER 12.26 MODIFICATION OR REVOCATION OF REGULATION OR ORDER Initiation Of Proceedings; Formal Evidentiary Public Hearing
ORDER 12.38 EFFECTIVE DATE OF AN ORDER Initiation Of Proceedings; Formal Evidentiary Public Hearing
ORDER 17.28 PROTECTIVE ORDER Civil Money Penalties Hearings
ORDER 20.83 DISCLOSURE REQUIRED BY COURT ORDER Limitations On Exemptions; Public Information
ORDER 514.120 REVOCATION OF ORDER REFUSING TO APPROVE AN APPLICATION OR SUSPENDING OR WITHDRAWING APPROVAL OF AN APPLICATION Administrative Actions On Applications; New Animal Drug Applications
ORDER 810.10 CEASE DISTRIBUTION AND NOTIFICATION ORDER Mandatory Medical Device Recall Procedures; Medical Device Recall Authority
ORDER 810.12 WRITTEN REQUEST FOR REVIEW OF CEASE DISTRIBUTION AND NOTIFICATION ORDER Mandatory Medical Device Recall Procedures; Medical Device Recall Authority
ORDER 810.13 MANDATORY RECALL ORDER Mandatory Medical Device Recall Procedures; Medical Device Recall Authority
ORDER 1301.37 ORDER TO SHOW CAUSE Action On Application For Registration: Revocation Or Suspension Of Registration; Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
ORDER 1309.46 ORDER TO SHOW CAUSE Registration Of Manufacturers, Distributors, Importers And Exporters Of List I Chemicals
ORDER, FINAL 58.206 FINAL ORDER ON DISQUALIFICATION Disqualification Of Testing Facilities; Good Laboratory Practice For Nonclinical Laboratory Studies
ORDER, FINAL 1301.36 SUSPENSION OF REGISTRATION; SUSPENSION PENDING FINAL ORDER; EXTENSION OF REGISTRATION PENDING FINAL ORDER
Hearings; Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
ORDER, FINAL 1303.37 FINAL ORDER Hearings; Quotas
ORDER, FINAL 1308.45 FINAL ORDER Hearings; Schedules Of Controlled Substances
ORDER, FINAL 1309.44 SUSPENSION OF REGISTRATION PENDING FINAL ORDER Registration Of Manufacturers, Distributors, Importers And Exporters Of List I Chemicals
ORDER, FINAL 1309.45 EXTENSION OF REGISTRATION PENDING FINAL ORDER Registration Of Manufacturers, Distributors, Importers And Exporters Of List I Chemicals
ORDER, FINAL 1312.47 FINAL ORDER Hearings; Importation And Exportation Of Controlled Substances
ORDER, FINAL 1313.57 FINAL ORDER Hearings; Importation And Exportation Of Precursors And Essential Chemicals
ORDER, FINAL 1316.67 FINAL ORDER Administrative Hearings; Administrative Functions, Practices, And Procedures
ORDER FORMS 1305.03 DISTRIBUTIONS REQUIRING ORDER FORMS Order Forms
ORDER FORMS 1305.04 PERSONS ENTITLED TO OBTAIN AND EXECUTE ORDER FORMS Order Forms
ORDER FORMS 1305.05 PROCEDURE FOR OBTAINING ORDER FORMS Order Forms
ORDER FORMS 1305.06 PROCEDURE FOR EXECUTING ORDER FORMS Order Forms
ORDER FORMS 1305.08 PERSONS ENTITLED TO FILL ORDER FORMS Order Forms
ORDER FORMS 1305.09 PROCEDURE FOR FILLING ORDER FORMS Order Forms
ORDER FORMS 1305.10 PROCEDURE FOR ENDORSING ORDER FORMS Order Forms
ORDER FORMS 1305.11 UNACCEPTED AND DEFECTIVE ORDER FORMS Order Forms
ORDER FORMS 1305.12 LOST AND STOLEN ORDER FORMS Order Forms
ORDER FORMS 1305.13 PRESERVATION OF ORDER FORMS Order Forms
ORDER FORMS 1305.14 RETURN OF UNUSED ORDER FORMS Order Forms
ORDER FORMS 1305.15 CANCELLATION AND VOIDING OF ORDER FORMS Order Forms
ORDER FORMS 1305.16 SPECIAL PROCEDURE FOR FILLING CERTAIN ORDER FORMS Order Forms
ORDER, RECALL 810.13 MANDATORY RECALL ORDER Mandatory Medical Device Recall Procedures; Medical Device Recall Authority
ORDER, RECALL 810.15 COMMUNICATIONS CONCERNING A CEASE DISTRIBUTION AND NOTIFICATION OR MANDATORY RECALL ORDER Mandatory Medical Device Recall Procedures; Medical Device Recall Authority
ORDER, RECALL 810.16 CEASE DISTRIBUTION AND NOTIFICATION OR MANDATORY RECALL ORDER STATUS REPORTS Mandatory Medical Device Recall Procedures; Medical Device Recall Authority
ORDER, RECALL 810.17 TERMINATION OF A CEASE DISTRIBUTION AND NOTIFICATION OR MANDATORY RECALL ORDER Mandatory Medical Device Recall Procedures; Medical Device Recall Authority
ORDERS 5.34 ISSUANCE OF NOTICES RELATING TO PROPOSALS AND ORDERS FOR DEBARMENT AND DENIAL OF AN APPLICATION TO TERMINATE DEBARMENT General Redelegations Of Authority; Delegations Of Authority And Organization
ORDERS 5.301 ISSUANCE OF INITIAL EMERGENCY PERMIT ORDERS AND NOTICES OF CONFIRMATION OF EFFECTIVE DATE OF FINAL REGULATIONS ON FOOD FOR HUMAN AND ANIMAL CONSUMPTION Foods And Cosmetics; Redelegations Of Authority; Delegations Of Authority And Organization
ORDERS 5.410 ORDERS TO REPAIR OR REPLACE, OR MAKE REFUNDS FOR, MEDICAL DEVICES Medical Devices And Radiological Health; Redelegations Of Authority; Delegations Of Authority And Organization
ORDERS 5.502 ISSUANCE OF NOTICES, PROPOSALS, AND ORDERS RELATING TO NEW ANIMAL DRUGS AND MEDICATED FEED MILL LICENSE APPLICATIONS Animal Drugs; Redelegations Of Authority; Delegations Of Authority And
FOR A FORMAL EVIDENTIARY PUBLIC HEARING General Administrative Procedures; Administrative Practices And Procedures
ORDERS 514.121 SERVICE OF NOTICES AND ORDERS Administrative Actions On Applications; New Animal Drug Applications
ORDERS 515.26 SERVICE OF NOTICES AND ORDERS Administrative Actions On Licenses; Medicated Feed Mill License
ORDERS 530.25 ORDERS PROHIBITING EXTRALABEL USES FOR DRUGS IN FOODPRODUCING ANIMALS Extralabel Drug Use In Animals
ORDERS 810.4 SERVICE OF ORDERS Medical Device Recall Authority
ORDERS 814.17 SERVICE OF ORDERS General; Premarket Approval Of Medical Devices
OREGON 808.87 OREGON Listing Of Specific State And Local Exemptions; Exemption From Federal Preemption Of State & Local Medical Device Requirements
ORGAN BAG 878.4100 ORGAN BAG Surgical Devices; General And Plastic Surgery Devices
ORGANIZATION 10.105 REPRESENTATION BY AN ORGANIZATION General Administrative Procedures; Administrative Practices And Procedures
ORGANIZATION 1401.2 THE OFFICE OF NATIONAL DRUG CONTROL POLICY - ORGANIZATION AND FUNCTIONS Public Availability Of Information
ORGANIZATIONS 20.108 AGREEMENTS BETWEEN THE FDA AND OTHER DEPARTMENTS, AGENCIES, AND ORGANIZATIONS Availability Of Specific Categories Of Records; Public Information
ORGANOTIN 178.2650 ORGANOTIN STABILIZERS IN VINYL CHLORIDE PLASTICS Antioxidants And Stabilizers; Indirect Food Additives: Adjuvants, Production Aids, And Sanitizers
ORGOTEIN 522.1620 ORGOTEIN FOR INJECTION Implantation Or Injectable Dosage Form New Animal Drugs
ORIGIN 864.9160 BLOOD GROUP SUBSTANCES OF NONHUMAN ORIGIN FOR IN VITRO DIAGNOSTIC USE Products Used In Establishments That Manufacture Blood And Blood Products; Hematology And Pathology Devices
ORMETOPRIM 520.2220d SULFADIMETHOXINE-ORMETOPRIM TABLETS Oral Dosage Form New Animal Drugs
ORMETOPRIM 556.490 ORMETOPRIM Specific Tolerances For Residues Of New Animal Drugs; Tolerances For Residues Of New Animal Drugs In Food
ORMETOPRIM 558.575 SULFADIMETHOXINE, ORMETOPRIM Specific New Animal Drugs For Use In Animal Feeds; New Animal Drugs For Use In Animal Feeds
ORNAMENTAL CERAMICWARE 109.16 ORNAMENTAL AND DECORATIVE CERAMICWARE Unavoidable Contaminants In Food For Human Consumption An Food Packaging Materials
ORNITHINE 862.1535 ORNITHINE CARBAMYL TRANSFERASE TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices
OROPHARYNGEAL 868.5110 OROPHARYNGEAL AIRWAY Therapeutic Devices; Anesthesiology Devices
ORPHAN-DRUG 316.20 CONTENT AND FORMAT OF A REQUEST FOR ORPHAN-DRUG DESIGNATION Designation Of An Orphan Drug; Orphan Drugs
ORPHAN-DRUG 316.21 VERIFICATION OF ORPHAN-DRUG STATUS Designation Of An Orphan Drug; Orphan Drugs
ORPHAN-DRUG 316.23 TIMING OF REQUESTS FOR ORPHAN-DRUG DESIGNATION; DESIGNATION OF ALREADY APPROVED DRUGS Designation Of An Orphan Drug; Orphan Drugs
ORPHAN-DRUG 316.24 GRANTING ORPHAN-DRUG STATUS Designation Of An Orphan Drug; Orphan Drugs
ORPHAN-DRUG 316.25 REFUSAL TO GRANT ORPHAN-DRUG DESIGNATION Designation Of An Orphan Drug; Orphan Drugs
ORPHAN-DRUG 316.26 AMENDMENT TO ORPHAN-DRUG DESIGNATION Designation Of An Orphan Drug; Orphan Drugs
ORPHAN-DRUG 316.27 CHANGE IN OWNERSHIP OF ORPHAN-DRUG DESIGNATION Designation Of An Orphan Drug; Orphan Drugs
ORPHAN-DRUG 316.28 PUBLICATION OF ORPHAN-DRUG DESIGNATIONS Designation Of An Orphan Drug; Orphan Drugs
ORPHAN-DRUG 316.29 REVOCATION OF ORPHAN-DRUG DESIGNATION Designation Of An Orphan Drug; Orphan Drugs
Orphan-Drug Exclusive Approval; Orphan Drugs
ORPHAN DRUG 316.40 TREATMENT USE OF A DESIGNATED ORPHAN DRUG Open Protocols For Investigations; Orphan Drugs
ORPHAN DRUGS 316.36 INSUFFICIENT QUANTITIES OF ORPHAN DRUGS Orphan-Drug Exclusive Approval; Orphan Drugs
ORPHAN PRODUCTS 5.900 ORPHAN PRODUCTS Orphan Products; Redelegations Of Authority; Delegations Of Authority And Organization
ORTHODONTIC 872.5410 ORTHODONTIC APPLIANCE AND ACCESSORIES Therapeutic Devices; Dental Devices
ORTHODONTIC 872.5470 ORTHODONTIC PLASTIC BRACKET Therapeutic Devices; Dental Devices
ORTHODONTIC 872.5500 EXTRAORAL ORTHODONTIC HEADGEAR Therapeutic Devices; Dental Devices
ORTHOPEDIC 888.4540 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Surgical Devices; Orthopedic Devices
ORTHOPEDIC 888.5850 NONPOWERED ORTHOPEDIC TRACTION APPARATUS AND ACCESSORIES Surgical Devices; Orthopedic Devices
ORTHOSIS, CRANIAL 882.5970 CRANIAL ORTHOSIS Neurological Therapeutic Devices; Neurological Devices
ORTHOSIS, FIXATION 888.3050 SPINAL INTERLAMINAL FIXATION ORTHOSIS Prosthetic Devices; Orthopedic Devices
ORTHOSIS, FIXATION 888.3060 SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS Prosthetic Devices; Orthopedic Devices
ORTHOSIS, LIMB 890.3474 LIMB ORTHOSIS Physical Medicine Prosthetic Devices; Physical Medicine Devices
ORTHOSIS, PNEUMATIC 890.3610 RIGID PNEUMATIC STRUCTURE ORTHOSIS Physical Medicine Prosthetic Devices; Physical Medicine Devices
ORTHOSIS, TRUNCAL 890.3490 TRUNCAL ORTHOSIS Physical Medicine Prosthetic Devices; Physical Medicine Devices
ORTHOTIC 890.3025 PROSTHETIC AND ORTHOTIC ACCESSORY Physical Medicine Prosthetic Devices; Physical Medicine Devices
ORTHOTIC 890.3410 EXTERNAL LIMB ORTHOTIC COMPONENT Physical Medicine Prosthetic Devices; Physical Medicine Devices
OSCILLOMETER 870.2675 OSCILLOMETER Cardiovascular Monitoring Devices; Cardiovascular Devices
OSMOLALITY 862.1540 OSMOLALITY TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices
OSMOMETER 862.2730 OSMOMETER FOR CLINICAL USE Clinical Laboratory Instruments; Clinical Chemistry And Clinical Toxicology Devices
OSMOSIS, REVERSE 177.2550 REVERSE OSMOSIS MEMBRANES Substances For Use Only As Components Of Articles Intended For Repeated Use; Indirect Food Additives: Polymers
OSMOTIC FRAGILITY 864.6600 OSMOTIC FRAGILITY TEST Manual Hematology Devices; Hematology And Pathology Devices
OSSICULAR 874.3450 PARTIAL OSSICULAR REPLACEMENT PROSTHESIS Prosthetic Devices; Ear, Nose And Throat Devices
OSSICULAR 874.3495 TOTAL OSSICULAR REPLACEMENT PROSTHESIS Prosthetic Devices; Ear, Nose And Throat Devices
OSSICULAR 874.3540 PROSTHESIS MODIFICATION INSTRUMENT FOR OSSICULAR REPLACEMENT SURGERY Prosthetic Devices; Ear, Nose And Throat Devices
OSTEOPOROSIS 101.72 HEALTH CLAIMS: CALCIUM AND OSTEOPOROSIS Food Labeling
OSTOMY 876.5895 OSTOMY IRRIGATOR Therapeutic Devices; Gastroenterology-urology Devices
OSTOMY 876.5900 OSTOMY POUCH AND ACCESSORIES Therapeutic Devices; Gastroenterology-urology Devices
OTC 201.66 FORMAT AND CONTENT REQUIREMENTS FOR OVER-THE-COUNTER (OTC) DRUG PRODUCT LABELING Labeling Requirements For Over-the-counter Drugs; Labeling
OTC 211.132 TAMPER-EVIDENT PACKAGING REQUIREMENTS FOR OVER-THE-COUNTER (OTC) HUMAN DRUG PRODUCTS Packaging And Labeling Control; Current Good Manufacturing Practice For Finished Pharmaceuticals
OTC 310.519 DRUG PRODUCTS MARKETED AS OVER-THE-COUNTER (OTC) DAYTIME SEDATIVES Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.527 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THE-
COUNTER (OTC) FOR USE AS AN APHRODISIAC Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.529 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR ORAL USE AS INSECT REPELLENTS Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.530 TOPICALLY APPLIED HORMONE-CONTAINING DRUG PRODUCTS FOR OVERTHE-COUNTER (OTC) HUMAN USE Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.531 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR THE TREATMENT OF BOILS Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.532 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) TO RELIEVE THE SYMPTOMS OF BENIGN PROSTATIC HYPERTROPHY Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.533 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR HUMAN USE AS AN ANTICHOLINERGIC IN COUGHCOLD DRUG PRODUCTS Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.534 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR HUMAN USE AS ORAL WOUND HEALING AGENTS Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.536 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR USE AS A NAILBITING OR THUMBSUCKING DETERRENT Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.537 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR TREATMENT OF FEVER BLISTERS AND COLD SORES Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.538 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR USE FOR INGROWN TOENAIL RELIEF Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.540 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR USE AS STOMACH ACIDIFIERS Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.541 OVER-THE-COUNTER (OTC) DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED FOR USE IN THE TREATMENT OF HYPOPHOSPHATEMIA Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.542 OVER-THE-COUNTER (OTC) DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED FOR USE IN THE TREATMENT OF HYPERPHOSPHATEMIA Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.543 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR HUMAN USE IN EXOCRINE PANCREATIC INSUFFICIENCY Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.544 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR USE AS A SMOKING DETERRENT Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.545 DRUG PRODUCTS CONTAINING CERTAIN ACTIVE INGREDIENTS OFFERED OVER-THE-COUNTER (OTC) FOR CERTAIN USES Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.546 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR THE TREATMENT AND/OR PREVENTION OF NOCTURNAL LEG MUSCLE CRAMPS Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.547 DRUG PRODUCTS CONTAINING QUININE OFFERED OVER-THE-COUNTER (OTC) FOR THE TREATMENT AND/OR PREVENTION OF MALARIA Requirements For Specific New Drugs Or Devices; New Drugs
OTC 310.548 DRUG PRODUCTS CONTAINING COLLOIDAL SILVER INGREDIENTS OFFERED OVER-THE-COUNTER (OTC) FOR THE TREATMENT OF DISEASE Requirements For Specific New Drugs Or Devices; New Drugs
OTC 328.50 PRINCIPAL DISPLAY PANEL OF ALL OTC DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL Over-the-counter Drug Products Intended For Oral Ingestion That Contain Alcohol
OTC 330.10 PROCEDURES FOR CLASSIFYING OTC DRUGS AS GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED Administrative Procedures; Over-the-counter Human Drugs Generally Recognized As Safe And Effective & Not Misbranded
UNDER THE DRUG EFFICACY STUDY (DESI) Administrative Procedures; Over-the-counter Human Drugs Generally Recognized As Safe And Effective & Not Misbranded
OTC 330.13 CONDITIONS FOR MARKETING INGREDIENTS RECOMMENDED FOR OVERTHE-COUNTER (OTC) USE UNDER THE OTC DRUG REVIEW Administrative Procedures; Over-the-counter Human Drugs Generally Recognized As Safe And Effective & Not Misbranded
OTC 341.70 LABELING OF OTC DRUG PRODUCTS CONTAINING INGREDIENTS THAT ARE USED FOR TREATING CONCURRENT SYMPTOMS Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For OTC Human Use
OTC 809.40 RESTRICTIONS ON THE SALE, DISTRIBUTION AND USE OF OTC TEST SAMPLE COLLECTION SYSTEMS FOR DRUGS OF ABUSE TESTING Requirements For Manufacturers And Producers; In Vitro Diagnostic Products For Human Use
OTC 864.3260 OTC TEST SAMPLE COLLECTION SYSTEMS FOR DRUGS OF ABUSE TESTING Pathology Instrumentation And Accessories; Hematology And Pathology Devices
OTC 872.3520 OTC DENTURE CLEANSER Prosthetic Devices; Dental Devices
OTC 872.3540 OTC DENTURE CUSHION OR PAD Prosthetic Devices; Dental Devices
OTC 872.3560 OTC DENTURE RELINER Prosthetic Devices; Dental Devices
OTC 872.3570 OTC DENTURE REPAIR KIT Prosthetic Devices; Dental Devices
OTIC 524.981e FLUOCINOLONE ACETONIDE, DIMETHYL SULFOXIDE OTIC SOLUTION Ophthalmic And Topical Dosage Form New Animal Drugs
OTIC 524.1044b GENTAMICIN SULFATE, BETAMETHASONE VALERATE OTIC SOLUTION Ophthalmic And Topical Dosage Form New Animal Drugs
OTIC 524.1044h GENTAMICIN SULFATE, MOMETASONE FUROATE, CLOTRIMAZOLE OTIC SUSPENSION Ophthalmic And Topical Dosage Form New Animal Drugs
OTIC 524.1195 IVERMECTIN OTIC SUSPENSION Ophthalmic And Topical Dosage Form New Animal Drugs
OTIC 524.1484k NEOMYCIN SULFATE, PREDNISOLONE, TETRACAINE, AND SQUALANE TOPICAL-OTIC SUSPENSION Ophthalmic And Topical Dosage Form New Animal Drugs
OTOLOGY 874.4490 ARGON LASER FOR OTOLOGY, RHINOLOGY, AND LARYNGOLOGY Surgical Devices; Ear, Nose, And Throat Devices
OTOSCOPE 874.4770 OTOSCOPE Surgical Devices; Ear, Nose, And Throat Devices
OUCHTERLONY 866.4600 OUCHTERLONY AGAR PLATE Immunology Laboratory Equipment And Reagents; Immunology And Microbiology Devices
OUTSIDE THE U.S. 814.15 RESEARCH CONDUCTED OUTSIDE THE UNITED STATES General; Premarket Approval Of Medical Devices
OVENS, MICROWAVE 1030.10 MICROWAVE OVENS Performance Standards For Microwave And Radio Frequency Emitting Products
OVER-THE-COUNTER 201.21 DECLARATION OF PRESENCE OF PHENYLALANINE AS A COMPONENT OF ASPARTAME IN OVER-THE-COUNTER AND PRESCRIPTION DRUGS FOR HUMAN USE General Labeling Provisions; Labeling
OVER-THE-COUNTER 201.66 FORMAT AND CONTENT REQUIREMENTS FOR OVER-THE-COUNTER (OTC) DRUGS PRODUCT LABELING Labeling Requirements For Over-the-counter Drugs; Labeling
OVER-THE-COUNTER 201.307 SODIUM PHOSPHATES, PACKAGE SIZE LIMITATION, WARNINGS AND DIRECTIONS FOR OVER-THE-COUNTER SALE Specific Labeling Requirements For Specific Drug Products; Labeling
OVER-THE-COUNTER 201.308 IPECAC SYRUP; WARNINGS AND DIRECTIONS FOR USE FOR OVER-THECOUNTER SALE Specific Labeling Requirements For Specific Drug Products; Labeling
OVER-THE-COUNTER 201.315 OVER-THE-COUNTER DRUGS FOR MINOR SORE THROATS; SUGGESTED WARNING Specific Labeling Requirements For Specific Drug Products; Labeling
OVER-THE-COUNTER 201.322 OVER-THE-COUNTER DRUG PRODUCTS CONTAINING INTERNAL ANALGESIC/ANTIPYRETIC ACTIVE INGREDIENTS; REQUIRED ALCOHOL WARNING Specific Labeling Requirements For Specific Drug Products; Labeling
OVER-THE-COUNTER 211.132 TAMPER-EVIDENT PACKAGING REQUIREMENTS FOR OVER-THE-COUNTER (OTC) HUMAN DRUG PRODUCTS
SEDATIVES Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.527 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR EXTERNAL USE A HAIR GROWERS OR FOR HAIR LOSS PREVENTION Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.528 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR USE AS AN APHRODISIAC Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.529 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR ORAL USE AS INSECT REPELLENTS Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.530 TOPICALLY APPLIED HORMONE-CONTAINING DRUG PRODUCTS FOR OVERTHE-COUNTER (OTC) FOR HUMAN USE Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.531 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR THE TREATMENT OF BOILS Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.532 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) TO RELIEVE THE SYMPTOMS OF BENIGN PROSTATIC HYPERTROPHY Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.533 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR HUMAN USE AS AN ANTICHOLINERGIC IN COUGHCOLD DRUG PRODUCTS Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.534 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR HUMAN USE AS ORAL WOUND HEALING AGENTS Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.536 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR USE AS A NAILBITING OR THUMBSUCKING DETERRENT Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.537 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR TREATMENT OF FEVER BLISTERS AND COLD SORES Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.538 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR USE FOR INGROWN TOENAIL RELIEF Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.540 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR USE AS STOMACH ACIDIFIERS Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.541 OVER-THE-COUNTER (OTC) DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED FOR USE IN THE TREATMENT OF HYPOPHOSPHATEMIA Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.542 OVER-THE-COUNTER (OTC) DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED FOR USE IN THE TREATMENT OF HYPERPHOSPHATEMIA Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.543 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR HUMAN USE IN EXOCRINE PANCREATIC INSUFFICIENCY Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.544 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR USE AS A SMOKING DETERRENT Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.545 DRUG PRODUCTS CONTAINING CERTAIN ACTIVE INGREDIENTS OFFERED OVER-THE-COUNTER (OTC) FOR CERTAIN USES Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.546 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR THE TREATMENT AND/OR PREVENTION OF NOCTURNAL LEG MUSCLE CRAMPS Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.547 DRUG PRODUCTS CONTAINING QUININE OFFERED OVER-THE-COUNTER (OTC) FOR THE TREATMENT AND/OR PREVENTION OF MALARIA Requirements For Specific New Drugs Or Devices; New Drugs
OVER-THE-COUNTER 310.548 DRUG PRODUCTS CONTAINING COLLOIDAL SILVER INGREDIENTS OFFERED OVER-THE-COUNTER (OTC) FOR THE TREATMENT OF DISEASE Requirements For Specific New Drugs Or Devices; New Drugs
UNDER THE DRUG EFFICACY STUDY (DESI) Administrative Procedures; Over-the-counter Human Drugs Generally Recognized As Safe And Effective & Not Misbranded
OVER-THE-COUNTER 330.13 CONDITIONS FOR MARKETING INGREDIENTS RECOMMENDED FOR OVERTHE-COUNTER (OTC) USE UNDER THE OTC DRUG REVIEW Administrative Procedures; Over-the-counter Human Drugs Generally Recognized As Safe And Effective & Not Misbranded
OVERLOAD 890.5575 POWERED EXTERNAL LIMB OVERLOAD WARNING DEVICE Physical Medicine Therapeutic Devices; Physical Medicine Devices
OWNERSHIP 314.72 CHANGE IN OWNERSHIP OF AN APPLICATION Applications; Applications For FDA Approval To Market A New Drug
OWNERSHIP 316.27 CHANGE IN OWNERSHIP OF ORPHAN-DRUG DESIGNATION Orphan Drugs
OX BILE EXTRACT 184.1560 OX BILE EXTRACT Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
OXALATE 862.1542 OXALATE TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices
OXFENDAZOLE 520.1628 OXFENDAZOLE POWDER AND PELLETS Oral Dosage Form New Animal Drugs
OXFENDAZOLE 520.1629 OXFENDAZOLE PASTE Oral Dosage Form New Animal Drugs
OXFENDAZOLE 520.1630 OXFENDAZOLE SUSPENSION Oral Dosage Form New Animal Drugs
OXFENDAZOLE 520.1631 OXFENDAZOLE AND TRICHLORFON PASTE Oral Dosage Form New Animal Drugs
OXFENDAZOLE 556.495 OXFENDAZOLE Specific Tolerances For Residues Of New; Tolerance For Residues Of New Animal Drugs In Food
OXIBENDAZOLE 520.623 DIETHYLCARBAMAZINE CITRATE, OXIBENDAZOLE CHEWABLE TABLETS Oral Dosage Form New Animal Drugs
OXIBENDAZOLE 520.1638 OXIBENDAZOLE PASTE Oral Dosage Form New Animal Drugs
OXIBENDAZOLE 520.1640 OXIBENDAZOLE SUSPENSION Oral Dosage Form New Animal Drugs
OXIDASE SCREENING 866.2420 OXIDASE SCREENING TEST FOR GONORRHEA Microbiology Devices; Immunology And Microbiology Devices
OXIDATIVELY REFINED 178.3770 POLYHYDRIC ALCOHOL DIESTERS OF OXIDATIVELY REFINED (GERSTHOFEN PROCESS) MONTAN WAX ACIDS Certain Adjuvants And Production Aids; Indirect Food Additives: Adjuvants, Production Aids, And Sanitizers
OXIDE 177.2460 POLY(2,6-DIMETHYL-1,4-PHENYLENE) OXIDE RESINS Substances For Use Only As Components Of Articles Intended For Repeated Use; Indirect Food Additives: Polymers
OXIDE, CALCIUM 184.1210 CALCIUM OXIDE Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
OXIDE, CALCIUM 582.1210 CALCIUM OXIDE General Purpose Food Additives; Substances Generally Recognized As Safe
OXIDE, CALCIUM 582.5210 CALCIUM OXIDE Nutrients And/or Dietary Supplements; Substances Generally Recognized As Safe
OXIDE, CHROMIUM 73.1015 CHROMIUM-COBALT-ALUMINUM OXIDE Drugs; Listing Of Color Additives Exempt From Certification
OXIDE, CHROMIUM 73.1327 CHROMIUM OXIDE GREENS Drugs; Listing Of Color Additives Exempt From Certification
OXIDE, CHROMIUM 73.2327 CHROMIUM OXIDE GREENS Cosmetics; Listing Of Color Additives Exempt From Certification
OXIDE, CHROMIUM 73.3110a CHROMIUM-COBALT-ALUMINUM OXIDE Medical Devices; Listing Of Color Additives Exempt From Certification
OXIDE, CHROMIUM 73.3111 CHROMIUM OXIDE GREENS Medical Devices; Listing Of Color Additives Exempt From Certification
OXIDE, ETHYLENE 172.770 ETHYLENE OXIDE POLYMER Other Specific Usage Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
OXIDE, ETHYLENE 172.808 COPOLYMER CONDENSATES OF ETHYLENE OXIDE AND PROPYLENE OXIDE Multipurpose Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
OXIDE, ETHYLENE 872.3410 ETHYLENE OXIDE HOMOPOLYMER AND/OR CARBOXYMETHYLCELLULOSE SODIUM DENTURE ADHESIVE
General Hospital And Personal Use Miscellaneous Devices; General Hospital And Personal Use Devices
OXIDE, ETHYLENE 880.6860 ETHYLENE OXIDE GAS STERILIZER General Hospital And Personal Use Miscellaneous Devices; General Hospital And Personal Use Devices
OXIDE, FERRIC 186.1300 FERRIC OXIDE Listing Of Specific Substances Affirmed As GRAS; Indirect Food Substances Affirmed As Generally Recognized As Safe
OXIDE, FERRIC 522.940 COLLOIDAL FERRIC OXIDE INJECTION Implantation Or Injectable Dosage Form New Animal Drugs
OXIDE, IRON 73.200 SYNTHETIC IRON OXIDE Foods; Listing Of Color Additives Exempt From Certification
OXIDE, IRON 73.1200 SYNTHETIC IRON OXIDE Drugs; Listing Of Color Additives Exempt From Certification
OXIDE, MAGNESIUM 184.1431 MAGNESIUM OXIDE Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
OXIDE, MAGNESIUM 582.1431 MAGNESIUM OXIDE General Purpose Food Additives; Substances Generally Recognized As Safe
OXIDE, MAGNESIUM 582.5431 MAGNESIUM OXIDE Nutrients And/or Dietary Supplements; Substances Generally Recognized As Safe
OXIDE, MANGANOUS 582.5464 MANGANOUS OXIDE Nutrients And/or Dietary Supplements; Substances Generally Recognized As Safe
OXIDE, NITRIC 868.2380 NITRIC OXIDE ANALYZER Monitoring Devices; Anesthesiology Devices
OXIDE, NITRIC 868.5165 NITRIC OXIDE ADMINISTRATION APPARATUS Therapeutic Devices; Anesthesiology Devices
OXIDE, NITROUS 184.1545 NITROUS OXIDE Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
OXIDE, NITROUS 868.1700 NITROUS OXIDE GAS ANALYZER Diagnostic Devices; Anesthesiology Devices
OXIDE, ZINC 73.1991 OXIDE Drugs; Listing Of Color Additives Exempt From Certification
OXIDE, ZINC 73.2991 ZINC OXIDE Cosmetics; Listing Of Color Additives Exempt From Certification
OXIDE, ZINC 182.8991 ZINC OXIDE Nutrients; Substances Generally Recognized As Safe
OXIDE, ZINC 582.599 ZINC OXIDE Nutrients And/or Dietary Supplements; Substances Generally Recognized As Safe
OXIDES, IRON 73.2250 IRON OXIDES Cosmetics; Listing Of Color Additives Exempt From Certification
OXIDES, IRON 73.3125 IRON OXIDES Medical Devices; Listing Of Color Additives Exempt From Certification
OXIDES, IRON 186.1374 IRON OXIDES Listing Of Specific Substances Affirmed As GRAS; Indirect Food Substances Affirmed As Generally Recognized As Safe
OXIDIZED POLYETHYLENE 172.260 OXIDIZED POLYETHYLENE Coatings, Films And Related Substances; Food Additives Permitted For Direct Addition To Food For Human Consumption
OXIDIZED POLYETHYLENE 177.1620 POLYETHYLENE, OXIDIZED Substances For Use As Basic Components Of Single And Repeated Use Food Contact Surfaces; Indirect Food Additives: Polymers
OXIME, MILBEMYCIN 520.1445 MILBEMYCIN OXIME TABLETS Oral Dosage Form New Animal Drugs
OXIME, MILBEMYCIN 520.1446 MILBEMYCIN OXIME/LUFENURON TABLETS Oral Dosage Form New Animal Drugs
OXIME, MILBEMYCIN 524.1446 MILBEMYCIN OXIME SOLUTION Ophthalmic And Topical Dosage Form New Animal Drugs
OXIMETER 870.1230 FIBEROPTIC OXIMETER CATHETER Cardiovascular Diagnostic Devices; Cardiovascular Devices
OXIMETER 870.2700 OXIMETER Cardiovascular Monitoring Devices; Cardiovascular Devices
OXIMETER 870.2710 EAR OXIMETER Cardiovascular Monitoring Devices; Cardiovascular Devices
OXYCHLORIDE 73.1162 BISMUTH OXYCHLORIDE Drugs; Listing Of Color Additives Exempt From Certification
OXYCHLORIDE 73.2162 BISMUTH OXYCHLORIDE Cosmetics; Listing Of Color Additives Exempt From Certification
OXYETHYLENE 177.1345 ETHYLENE/1,3-PHENYLENE OXYETHYLENE
Diagnostic Devices; Anesthesiology Device
OXYGEN ANALYZER 868.1720 OXYGEN GAS ANALYZER Diagnostic Devices; Anesthesiology Devices
OXYGEN CANNULA 868.5340 NASAL OXYGEN CANNULA Therapeutic Devices; Anesthesiology Devices
OXYGEN CATHETER 868.5350 NASAL OXYGEN CATHETER Therapeutic Devices; Anesthesiology Devices
OXYGEN CHAMBER 878.5650 TOPICAL OXYGEN CHAMBER FOR EXTREMITIES Therapeutic Devices; General And Plastic Surgery Devices
OXYGEN GENERATOR 868.5440 PORTABLE OXYGEN GENERATOR Therapeutic Devices; Anesthesiology Devices
OXYGEN MASK 868.5580 OXYGEN MASK Therapeutic Devices; Anesthesiology Devices
OXYGEN MONITOR 868.2500 CUTANEOUS OXYGEN MONITOR Monitoring Devices; Anesthesiology Devices
OXYGEN TENT 868.5700 NONPOWERED OXYGEN TENT Therapeutic Devices; Anesthesiology Devices
OXYGEN TENT 868.5710 ELECTRICALLY POWERED OXYGEN TENT Therapeutic Devices; Anesthesiology Devices
OXYGEN UNIT 868.5655 PORTABLE LIQUID OXYGEN UNIT Therapeutic Devices; Anesthesiology Devices
OXYGEN UPTAKE 868.1730 OXYGEN UPTAKE COMPUTER Diagnostic Devices; Anesthesiology Devices
OXYGENATOR 870.4350 CARDIOPULMONARY BYPASS OXYGENATOR Cardiovascular Surgical Devices; Cardiovascular Devices
OXYHEMOGLOBIN 868.1120 INDWELLING BLOOD OXYHEMOGLOBIN CONCENTRATION ANALYZER Diagnostic Devices; Anesthesiology Devices
OXYMORPHONE 522.1642 OXYMORPHONE HYDROCHLORIDE INJECTION Implantation Or Injectable Dosage Form New Animal Drugs
OXYSTEARIN 172.818 OXYSTEARIN Multipurpose Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
OXYTETRACYCLINE 520.1660 OXYTETRACYCLINE Oral Dosage Form New Animal Drugs
OXYTETRACYCLINE 522.1660 OXYTETRACYCLINE INJECTION Implantation Or Injectable Dosage Form New Animal Drugs
OXYTETRACYCLINE 556.500 OXYTETRACYCLINE Specific Tolerances For Residues Of New Animal Drugs; Tolerances For Residues Of New Animal Drugs In Food
OXYTETRACYCLINE 558.450 OXYTETRACYCLINE Specific New Animal Drugs For Use In Animal Feeds; New Animal Drugs For Use In Animal Feeds
OXYTETRACYCLINE HCL 520.1660 OXYTETRACYCLINE HYDROCHLORIDE CAPSULES Oral Dosage Form New Animal Drugs
OXYTETRACYCLINE HCL 522.1662 OXYTETRACYCLINE HYDROCHLORIDE IMPLANTATION OR INJECTABLE DOSAGE FORMS Implantation Or Injectable Dosage Form New Animal Drugs
OXYTETRACYCLINE HCL 524.1662 OXYTETRACYCLINE HYDROCHLORIDE OPHTHALMIC AND TOPICAL DOSAGE FORMS Ophthalmic And Topical Dosage Form New Animal Drugs
OXYTOCIN 522.1680 OXYTOCIN INJECTION Implantation Or Injectable Dosage Form New Animal Drugs
OYSTERS 161.30 DECLARATION OF QUANTITY OF CONTENTS ON LABELS FOR CANNED OYSTERS General Provisions; Fish And Shellfish
OYSTERS 161.130 OYSTERS Requirements For Specific Standardized Fish And Shellfish; Fish And Shellfish
OYSTERS 161.136 OLYMPIA OYSTERS Requirements For Specific Standardized Fish And Shellfish; Fish And Shellfish
OYSTERS 161.145 CANNED OYSTERS Requirements For Specific Standardized Fish And Shellfish; Fish And Shellfish
OZONE 173.368 OZONE Specific Usage Additives; Secondary Direct Food Additives Permitted In Food For Human Consumption
OZONE 184.1563 OZONE Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
OZONE 801.415 MAXIMUM ACCEPTABLE LEVEL OF OZONE Special Requirements For Specific Devices; Labeling
OZONE-DEPLETING 201.320 WARNING STATEMENTS FOR DRUG PRODUCTS CONTAINING OR
MANUFACTURED WITH CHLOROFLUOROCARBONS OR OTHER CLASS I OZONE-DEPLETING SUBSTANCES Labeling Requirements For Over-the-counter Devices; Labeling
OZONE-DEPLETING 801.433 WARNING STATEMENTS FOR PRESCRIPTION AND RESTRICTED DEVICE PRODUCTS CONTAINING CHLOROFLUOROCARBONS OR OTHER OZONEDEPLETING SUBSTANCES Specific Requirements For Specific Devices; Labeling
