Oral Dosage Form New Animal Drugs; Phenylpropanolamine
other · Food and Drug Administration · Rule · Published 2012-03-19 · Effective 2012-03-19 · 77 FR 15961
Document
Document number
2012-6553
Federal Register citation
77 FR 15961
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2012-03-19
Effective date
2012-03-19
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 Pegasus Laboratories, Inc. The NADA provides for the veterinary prescription use of phenylpropanolamine hydrochloride chewable tablets for the control of urinary incontinence due to urethral sphincter hypotonus in dogs.