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Oral Dosage Form New Animal Drugs; Estriol

other · Food and Drug Administration · Rule · Published 2011-12-16 · Effective 2011-12-16 · 76 FR 78149

Document

Document number
2011-32214
Federal Register citation
76 FR 78149
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2011-12-16
Effective date
2011-12-16
HHS docket
Docket No. FDA-2011-N-0003

Abstract

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of estriol tablets for the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.

Source

Authoritative
Federal Register document
Machine
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