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2010-10-30
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Oral Dosage Form New Animal Drugs; Domperidone
Rules and Regulations
D09002ee1be325584
D09002ee1be325612
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 reflect the original approval of a new animal drug application (NADA) filed by Dechra, Ltd. The NADA provides for the veterinary prescription use of domperidone oral gel for prevention of fescue toxicosis in periparturient mares.
75 FR 67031
https://www.govinfo.gov/app/details/FR-2010-11-01/2010-27524
2010-27524
FR01NO10-2
4160-01-P
Docket No. FDA-2010-N-0002
https://www.govinfo.gov/app/details/FR-2010-11-01/2010-27524
https://www.govinfo.gov/content/pkg/FR-2010-11-01/html/2010-27524.htm
https://www.govinfo.gov/content/pkg/FR-2010-11-01/pdf/2010-27524.pdf
Animal Drugs
1 p.
67031
67031
75 FR 67031
Code of Federal Regulations
Title 21 Part 520
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Domperidone; Federal Register Vol. 75, Issue
RULE
2010-27524
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2010-11-01
Docket No. FDA-2010-N-0002
4160-01-P
2010-27524
Final rule.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by Dechra, Ltd. The NADA provides for the veterinary prescription use of domperidone oral gel for prevention of fescue toxicosis in periparturient mares.
This rule is effective November 1, 2010.
Amy L. Omer, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8336, e-mail: amy.omer@fda.hhs.gov.
Animal Drugs
Oral Dosage Form New Animal Drugs:
Domperidone
,
amy.omer@fda.hhs.gov
Federal Register
Vol. 75, no. 210
Office of the Federal Register, National Archives and Records Administration
2010-11-01
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193 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2010-11-01
P0b002ee180b315fe
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:FR01NO10
https://www.govinfo.gov/app/details/FR-2010-11-01
https://www.govinfo.gov/content/pkg/FR-2010-11-01/pdf/FR-2010-11-01.pdf
https://www.govinfo.gov/content/pkg/FR-2010-11-01/xml/FR-2010-11-01.xml
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2010-10-30
2023-05-17
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FR-2010-11-01
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