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2010-02-20
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Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid
Rules and Regulations
D09002ee1bdd2434b
D09002ee1bdd243d2
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 new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for veterinarian prescription use of ceftiofur crystalline free acid injectable suspension for the treatment of lower respiratory tract infections in horses.
75 FR 4692
https://www.govinfo.gov/app/details/FR-2010-01-29/2010-1790
2010-1790
FR29JA10-4
4160-01-S
Docket No. FDA-2010-N-0002
https://www.govinfo.gov/app/details/FR-2010-01-29/2010-1790
https://www.govinfo.gov/content/pkg/FR-2010-01-29/html/2010-1790.htm
https://www.govinfo.gov/content/pkg/FR-2010-01-29/pdf/2010-1790.pdf
Animal Drugs
1 p.
4692
4692
75 FR 4692
Code of Federal Regulations
Title 21 Part 522
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid; Federal Register Vol. 75, Issue
RULE
2010-1790
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2010-01-29
Docket No. FDA-2010-N-0002
4160-01-S
2010-1790
Final rule.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for veterinarian prescription use of ceftiofur crystalline free acid injectable suspension for the treatment of lower respiratory tract infections in horses.
This rule is effective January 29, 2010.
Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: melanie.berson@fda.hhs.gov.
Animal Drugs
Implantation or Injectable Dosage Form New Animal Drugs:
Ceftiofur Crystalline Free Acid
,
melanie.berson@fda.hhs.gov
Federal Register
Vol. 75, no. 19
Office of the Federal Register, National Archives and Records Administration
2010-01-29
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299 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2010-01-29
P0b002ee180195c59
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:FR29JA10
https://www.govinfo.gov/app/details/FR-2010-01-29
https://www.govinfo.gov/content/pkg/FR-2010-01-29/pdf/FR-2010-01-29.pdf
https://www.govinfo.gov/content/pkg/FR-2010-01-29/xml/FR-2010-01-29.xml
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2010-02-20
2023-05-01
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FR-2010-01-29
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