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2010-09-22
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Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, Clotrimazole Ointment
Rules and Regulations
D09002ee1bde2033b
D09002ee1bde203ff
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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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Med-Pharmex, Inc. The supplemental ANADA provides for a new container size, a 15-gram bottle, from which gentamicin sulfate, betamethasone valerate, clotrimazole ointment may be dispensed for the treatment of acute and chronic canine otitis externa.
71 FR 16481
https://www.govinfo.gov/app/details/FR-2006-04-03/06-3149
06-3149
fr03ap06-2
4160-01-S
https://www.govinfo.gov/app/details/FR-2006-04-03/06-3149
https://www.govinfo.gov/content/pkg/FR-2006-04-03/html/06-3149.htm
https://www.govinfo.gov/content/pkg/FR-2006-04-03/pdf/06-3149.pdf
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71 FR 16481
Code of Federal Regulations
Title 21 Part 524
21 CFR Part 524
Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, Clotrimazole Ointment; Federal Register Vol. 71, Issue
RULE
06-3149
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2006-04-03
4160-01-S
06-3149
Final rule; technical amendment.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Med-Pharmex, Inc. The supplemental ANADA provides for a new container size, a 15-gram bottle, from which gentamicin sulfate, betamethasone valerate, clotrimazole ointment may be dispensed for the treatment of acute and chronic canine otitis externa.
This rule is effective April 3, 2006.
Christopher Melluso, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: christopher.melluso@fda.hhs.gov.
Animal drugs, feeds, and related products:
Gentamicin sulfate, betamethasone valerate, clotrimazole ointment; technical amendment,
christopher.melluso@fda.hhs.gov
Federal Register
Vol. 71, no. 63
Office of the Federal Register, National Archives and Records Administration
2006-04-03
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225 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-2006-04-03
https://www.govinfo.gov/content/pkg/FR-2006-04-03/pdf/FR-2006-04-03.pdf
https://www.govinfo.gov/content/pkg/FR-2006-04-03/xml/FR-2006-04-03.xml
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2010-09-22
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FR-2006-04-03
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