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Oral Dosage Form New Animal Drugs; Omeprazole

other · Food and Drug Administration · Rule · Published 1999-04-15 · Effective 1999-04-15 · 64 FR 18572

Document

Document number
99-9455
Federal Register citation
64 FR 18572
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1999-04-15
Effective date
1999-04-15

Abstract

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Merial Ltd. The NADA provides for oral use of omeprazole for the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.

Source

Authoritative
Federal Register document
Machine
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