Oral Dosage Form New Animal Drugs; Spectinomycin Dihydrochloride Oral Solution
other · Food and Drug Administration · Rule · Published 2004-08-30 · Effective 2004-08-30 · 69 FR 52815
Document
Document number
04-19655
Federal Register citation
69 FR 52815
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-08-30
Effective date
2004-08-30
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for the oral use of spectinomycin dihydrochloride pentahydrate oral solution in pigs under 4 weeks of age for the treatment and control of infectious bacterial enteritis.