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Certain Other Dosage Form New Animal Drugs; Gentamicin Sulfate Intrauterine Solution
Rules and Regulations
D09002ee1be059f34
D09002ee1be059fca
United States
Department of Health and Human Services
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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 an abbreviated new animal drug application (ANADA) filed by Macleod Pharmaceuticals, Inc. The ANADA provides for the use of a generic gentamicin solution for control of bacterial infections of the uterus (metritis) of horses and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
60 FR 45041
https://www.govinfo.gov/app/details/FR-1995-08-30/95-21455
95-21455
fr30au95-2
4160-01-F
https://www.govinfo.gov/app/details/FR-1995-08-30/95-21455
https://www.govinfo.gov/content/pkg/FR-1995-08-30/html/95-21455.htm
https://www.govinfo.gov/content/pkg/FR-1995-08-30/pdf/95-21455.pdf
2 p.
45041
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60 FR 45041
Code of Federal Regulations
Title 21 Part 529
21 CFR Part 529
Certain Other Dosage Form New Animal Drugs; Gentamicin Sulfate Intrauterine Solution; Federal Register Vol. 60, Issue
RULE
95-21455
DEPARTMENT OF HEALTH AND HUMAN SERVICES
4160-01-F
95-21455
Final rule.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Macleod Pharmaceuticals, Inc. The ANADA provides for the use of a generic gentamicin solution for control of bacterial infections of the uterus (metritis) of horses and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
August 30, 1995.
Sandra K. Woods, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1612.
Federal Register
Vol. 60, no. 168
Office of the Federal Register, National Archives and Records Administration
1995-08-30
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292 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
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https://www.govinfo.gov/app/details/FR-1995-08-30
https://www.govinfo.gov/content/pkg/FR-1995-08-30/pdf/FR-1995-08-30.pdf
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