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2010-09-23
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Implantation or Injectable Dosage Form New Animal Drugs; Dexamethasone Injection
Rules and Regulations
D09002ee1bdeb7b9c
D09002ee1bdeb7c7e
United States
Department of Health and Human Services
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org
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 reflect approval of an abbreviated new animal drug application (ANADA) filed by Veterinary Laboratories, Inc. The ANADA provides for the use of dexamethasone injectable solution for the treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle and horses.
68 FR 56765
https://www.govinfo.gov/app/details/FR-2003-10-02/03-24928
03-24928
fr02oc03-1
4160-01-S
https://www.govinfo.gov/app/details/FR-2003-10-02/03-24928
https://www.govinfo.gov/content/pkg/FR-2003-10-02/html/03-24928.htm
https://www.govinfo.gov/content/pkg/FR-2003-10-02/pdf/03-24928.pdf
1 p.
56765
56765
68 FR 56765
Code of Federal Regulations
Title 21 Part 522
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs; Dexamethasone Injection; Federal Register Vol. 68, Issue
RULE
03-24928
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2003-10-02
4160-01-S
03-24928
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 Veterinary Laboratories, Inc. The ANADA provides for the use of dexamethasone injectable solution for the treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle and horses.
This rule is effective October 2, 2003.
Lonnie W. Luther, Center for Veterinary Medicine (HFV 104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: lluther@cvm.fda.gov.
Animal drugs, feeds, and related products:
Dexamethasone injection,
lluther@cvm.fda.gov
Federal Register
Vol. 68, no. 191
Office of the Federal Register, National Archives and Records Administration
2003-10-02
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564 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-2003-10-02
https://www.govinfo.gov/content/pkg/FR-2003-10-02/pdf/FR-2003-10-02.pdf
https://www.govinfo.gov/content/pkg/FR-2003-10-02/xml/FR-2003-10-02.xml
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2010-09-23
2023-05-04
FR-2003-10-02
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FR-2003-10-02
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