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Oral Dosage Form New Animal Drugs; Clenbuterol

other · Food and Drug Administration · Rule · Published 1998-08-04 · Effective 1998-08-04 · 63 FR 41419

Document

Document number
98-20699
Federal Register citation
63 FR 41419
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-08-04
Effective date
1998-08-04

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 Boehringer Ingelheim Animal Health, Inc. The NADA provides for veterinary prescription use of clenbuterol syrup (clenbuterol hydrochloride) indicated for the management of horses affected with airway obstruction, such as occurs in chronic obstructive pulmonary disease (COPD).

Source

Authoritative
Federal Register document
Machine
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