Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora.
(27DEC01)
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The Draft Guidance |
New Animal Drugs; Change of Sponsor's Address. (27DEC01)
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International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on "Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSU's)" (VICH GL29); Request for Comments; Availability. (13DEC01)
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The Draft Guidance
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Import Tolerances; Extension of Comment Period. (07DEC01)
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New Animal Drugs; Change of Sponsor.
(07DEC01)
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New Animal Drugs for Use in Animal Feeds; Monensin. (07DEC01)
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Freedom of Information Summary |
Oral Dosage Form New Animal Drugs; Ivermectin Liquid. (05DEC01)
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Freedom of Information Summary |
New Animal Drugs; Change of Sponsor's Address. (05DEC01)
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Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Pour-On. (05DEC01)
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Freedom of Information Summary |
Oral Dosage Form New Animal Drugs; Carprofen. (05DEC01)
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Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Diclazuril. (04DEC01)
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Freedom of Information Summary
Finding of No Significant Impact |
Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder; Technical Amendment. (26NOV01)
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Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Fenbendazole; Technical Amendment. (26NOV01)
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Veterinary Medicine Advisory Committee; Notice of Meeting. (21NOV01)
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New Animal Drugs for Use in Animal Feeds; Arsanilic Acid; Technical Amendment. (19NOV01)
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Oxytetracycline in Fish; Availability of Data. (16NOV01)
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Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds; Availability. (09NOV01)
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The Guidance |
Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor. (06NOV01)
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New Animal Drugs; Change of Sponsor's Name. (06NOV01)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Veterinary Adverse Drug Reaction,
Lack of Effectiveness, Product Defect Report.
(05NOV01)
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Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational
Use. (16OCT01)
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Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practice Regulations
for Medicated Feeds. (15OCT01)
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Supporting Statement |
Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed; Public Hearing;
Request for Comments. (05OCT01)
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New Animal Drugs; Change of Sponsor; Technical Amendment. (17SEP01)
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New Animal Drugs; Change of Sponsor; Technical Amendment. (17SEP01)
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New Animal Drugs; Change of Sponsor.
(17SEP01)
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New Animal Drugs for Use in Animal Feeds; Lasalocid (Final rule). (11SEP01)
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Freedom of Information Summary |
New Animal Drugs; Change of Sponsor.
(07SEP01)
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Animal Drugs, Feeds, and Related Products; Technical Amendments. (06SEP01)
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New Animal Drugs; Change of Sponsor's Name and Address. (05SEP01)
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Ophthalmic and Topical Dosage Form New Animal Drugs; Change of Sponsor. (05SEP01)
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Oral Dosage Form New Animal Drugs; Marbofloxacin Tablets. (05SEP01)
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Freedom of Information Summary |
Ophthalmic and Topical Dosage Form New Animal Drugs; Moxidectin. (05SEP01)
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Tolerances for Residues of New Animal Drugs in Food; Oxytetracycline; Technical Amendment. (05SEP01)
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New Animal Drugs for Use in Animal Feeds; Lasalocid and Bacitracin Methylene Disalicylate. (05SEP01)
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Freedom of Information Summary |
Alpharma, Inc; Withdrawal of Approval of NADA. (03AUG01)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Adverse Drug Reaction, Lack of
Effectiveness, Product Defect Report; Reopening of Comment Period. (31AUG01)
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International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing (VICH GL28); Request for Comments; Availability. (28AUG01)
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The Draft Guidance
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New Animal Drugs for Use in Animal Feeds; Nequinate; Oxytetracycline; Technical Amendment. (28AUG01)
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New Animal Drugs; Change of Sponsor's Name and Address. (21AUG01)
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Oral Dosage Form New Animal Drugs; Ponazuril. (21AUG01)
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Freedom of Information Summary |
EVSCO Pharmaceuticals, an Affiliate of IGI, Inc.; Withdrawal of Approval of NADAs. (15AUG01)
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CVM 2000119. Ophthalmic and Topical Dosage Form New Animal Drugs; Chloramphenicol, etc.; Withdrawal of Approval of NADAs.
(15AUG01)
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CVM 1998109. Import Tolerances.
(10AUG01)
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Veterinary Medicine Advisory Committee; Notice of Meeting. (10AUG01)
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Alpharma, Inc; Withdrawal of Approval of NADA. (03AUG01)
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Agency Information Collection Activities; Announcement of OMB Approval; New Animal Drug Application, Form FDA 356 V.
(23JUL01)
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Supporting Statement
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Novus International, Inc.; Filing of Food Additive Petition (Animal Use)- Ethoxyquin phosphate. (13JUL01)
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Heinold Feeds, Inc.; Withdrawal of Approval of New Animal Drug Applications. (11JUL01)
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Animal Drugs, Feeds, and Related Products; Tylosin; Withdrawal of Approval of NADAs. (11JUL01)
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Oral Dosage Form New Animal Drugs; Chlortetracycline Powder. (10JUL01)
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Freedom of Information Summary |
Oral Dosage Form New Animal Drugs; Ivermectin and Pyrantel Pamoate Chewable Tablets. (09JUL01)
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Freedom of Information Summary |
Implantation or Injectable Dosage Form New Animal Drugs; Moxidectin. (09JUL01)
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Freedom of Information Summary |
Tolerances for Residues of New Animal Drugs in Food; Clorsulon. (06JUL01)
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Freedom of Information Summary |
New Animal Drugs; Change of Sponsor.
(18JUN01)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Current Good Manufacturing Practice
Regulations for Medicated Feeds. (15JUN01)
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Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Sterile Powder for Injection; (15JUN01)
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Freedom of Information Summary |
Draft Guidance for Industry: Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues; Availability.
(13JUN01)
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The Draft Guidance |
Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Adverse Drug Reaction, Lack of
Effectiveness, Product Defect Report (29MAY01)
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Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder. (29MAY01)
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Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Lasalocid and Bacitracin Zinc. (29MAY01)
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Freedom of Information Summary |
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Final Guidance for Industry on "Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients" (VICH GL18); Availability. (22MAY01)
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The Guidance
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New Animal Drugs For Use in Animal Feeds; Naracin, Nicarbazin, and Bambermycins. (16MAY01)
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Freedom of Information Summary |
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Final Guidance for Industry entitled Good Clinical Practice (VICH GL9); Availability (15MAY01)
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The Guidance |
Purina Mills, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications. (09MAY01)
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Animal Drugs, Feeds, and Related Products; Trichlorfonm etc.; Withdrawal of Approval of NADAs;. (09MAY01)
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Tolerances for Residues of New Animal Drugs in Food; Narasin. (09MAY01)
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Freedom of Information Summary |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; New Animal Drug Application, Form
356 V. (06MAY01)
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Elanco Animal Health, A Div. of Eli Lilly & Co. et al.; Withdrawal of Approval of NADAs. (03MAY01)
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Animal Drugs, Feeds, and Related Products; Tylosin Tartrate for Injection, etc.; Withdrawal of Approval of NADAs.
(03MAY01)
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Animal Drugs, Feeds, and Related Products; Technical Amendments. (03MAY01)
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New Animal Drugs for Use in Animal Feeds; Monensin, Sulfadimethoxine, and Ormetoprim; Technical Amendment. (02MAY01)
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Abbott Laboratories' Sarafloxacin for Poultry; Withdrawal of Approval of NADAs. (30APR01)
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Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder. (30APR01)
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Animal Drugs, Feeds, and Related Products; Sarafloxacin for Poultry; Withdrawal of Approval of NADAs. (30APR01)
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Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Sterile Powder for Injection. (30APR01)
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Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Ractopamine and Tylosin. (30APR01)
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Extra-Label Use of Medicated Feeds for Minor Species; Compliance Policy Guide; Availability. (23APR01)
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The Guidance |
New Animal Drugs for Use in Animal Feeds; Amprolium, Bacitracin Methylene Disalicylate, and Roxarsone. (23APR01)
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Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Amprolium and Bacitracin Methylene Disalicylate. (19APR01)
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Freedom of Information Summary |
Tolerances for Residues of New Animal Drugs in Food; Lasalocid. (18APR01)
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Freedom of Information Summary |
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Final Guidance for Industry Entitled "Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products"
(13APR01)
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The Guidance
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Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food; Irradiation. (10APR01)
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International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH);
Final Guidances entitled "Effectiveness of Anthelmintics: General Recommendations" (VICH GL7), "Effectiveness of Anthelmintics: Specific Recommendations for Bovine" (VICH GL12), "Effectiveness of Anthelmintics:
Specific Recommendations for Ovine" (VICH GL13), and "Effectiveness of Anthelmintics: Specific Recommendations for Caprine" (VICH GL14); Availability (06APR01)
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The Guidance
The Guidance
The Guidance
The Guidance |
New Animal Drugs; Change of Sponsor. (02APR01)
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New Animal Drugs for Use in Animal Feeds; Monensin and Tylosin. (23MAR01)
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New Animal Drugs; Change of Sponsor. (19MAR01)
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International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH);
Final Guidance on "Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's)-Phase I" (VICH GL6); Availability. (13MAR01)
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The Guidance |
Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets and Boluses. (12MAR01)
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Freedom of Information Summary |
Guidance for Industry: Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims;
Availability. (09MAR01)
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The Guidance
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New Animal Drugs; Change of Sponsor. (09MAR01)
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New Animal Drugs; Change of Sponsor Name and Address. (08MAR01)
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Oral Dosage Form New Animal Drugs; Clindamycin Hydrochloride Liquid,. (08MAR01)
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Freedom of Information Summary |
Ophthalmic and Topical Dosage Form New Animal Drugs; Milbemycin Oxime Solution. (08MAR01)
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Freedom of Information Summary |
New Animal Drugs; Change of Sponsor. (06MAR01)
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Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin. (05MAR01)
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Freedom of Information Summary |
Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection. (05MAR01)
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Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Monesin, Bacitracin Methylene Disalicylate, and Roxarsone. (05MAR01)
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Freedom of Information Summary |
Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Pour-On. (05MAR01)
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Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Monensin and Tylosin;. (05MAR01)
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Agency Information Collection Activities; Announcement of OMB Approval; Emergency Health Surveys. (02MAR01)
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Agency Information Collection Activities; Announcement of OMB Approval; Substances Prohibited From Use in Animal Food or
Feed; Animal Proteins Phohibited in Ruminant Feed. (02MAR01)
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Supporting Statement |
Agency Information Collection Activities; Announcement of OMB Approval; Substantial Evidence of Effectiveness of New
Animal Drugs (01MAR01)
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Supporting Statement |
Guidance for Industry on How to Use E-Mail to Submit Information to the Center for Veterinary Medicine;
Availability. (22FEB01)
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The Guidance |
Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes;
Availability. (22FEB01)
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The Guidance |
Guidance for Industry on How to Use E-Mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate
Slaughter; Availability (16FEB01)
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The Guidance |
Guidance for Industry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office of New Animal
Drug Evaluation; Availability (16FEB01)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice
Regulations for Medicated Feeds. (09FEB01)
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Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Chewable Tablets. (09FEB01)
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Freedom of Information Summary |
Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Suspension. (24JAN01)
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Freedom of Information Summary |
Oral Dosage Form New Animal Drugs; Ivermectin Liquid. (24JAN01)
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Freedom of Information Summary |
Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Application, Form FDA 356
V, 21 CFR Part 514 (23JAN01)
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Enrofloxacin for Poultry; Opportunity for Hearing; Correction. (22JAN01)
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Revised Risk Assessment
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New Animal Drugs for Use in Animal Feeds; Decoquinate, Monensin, and Tylosin. (10JAN01)
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Freedom of Information Summary |
Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor. (04JAN01)
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CV Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Mometasone Furoate, Clotrimazole Otic
Suspension. (04JAN01)
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Freedom of Information Summary |
