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2010-09-08
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Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Ophthalmic Solution
Rules and Regulations
D09002ee1bdd17851
D09002ee1bdd178e7
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is amending the animal drug regulations to codify the conditions of use of an approved new animal drug application (NADA) for gentamicin sulfate and betamethasone acetate ophthalmic solution. This action is being taken to comply with the Federal Food, Drug, and Cosmetic Act and to improve the accuracy of the regulations.
75 FR 54492
https://www.govinfo.gov/app/details/FR-2010-09-08/2010-22276
2010-22276
FR08SE10-6
4160-01-S
Docket No. FDA-2010-N-0002
https://www.govinfo.gov/app/details/FR-2010-09-08/2010-22276
https://www.govinfo.gov/content/pkg/FR-2010-09-08/html/2010-22276.htm
https://www.govinfo.gov/content/pkg/FR-2010-09-08/pdf/2010-22276.pdf
2 p.
54492
54493
75 FR 54492
Code of Federal Regulations
Title 21 Part 524
21 CFR Part 524
Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Ophthalmic Solution; Federal Register Vol. 75, Issue
RULE
2010-22276
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2010-09-08
Docket No. FDA-2010-N-0002
4160-01-S
2010-22276
Final rule; technical amendment.
The Food and Drug Administration (FDA) is amending the animal drug regulations to codify the conditions of use of an approved new animal drug application (NADA) for gentamicin sulfate and betamethasone acetate ophthalmic solution. This action is being taken to comply with the Federal Food, Drug, and Cosmetic Act and to improve the accuracy of the regulations.
This rule is effective September 8, 2010.
Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8337, email: melanie.berson@fda.hhs.gov.
Ophthalmic and Topical Dosage Form New Animal Drugs:
Gentamicin and Betamethasone Ophthalmic Solution; Technical Amendment
,
melanie.berson@fda.hhs.gov
Federal Register
Vol. 75, no. 173
Office of the Federal Register, National Archives and Records Administration
2010-09-08
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306 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-2010-09-08
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0042-1219
0364-1406
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https://www.govinfo.gov/app/details/FR-2010-09-08
https://www.govinfo.gov/content/pkg/FR-2010-09-08/pdf/FR-2010-09-08.pdf
https://www.govinfo.gov/content/pkg/FR-2010-09-08/xml/FR-2010-09-08.xml
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2010-09-08
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FR-2010-09-08
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FR-2010-09-08
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