Oral Dosage Form New Animal Drugs; Change of Sponsor; Lincomycin Hydrochloride Soluble Powder; Penicillin G Potassium in Drinking Water; Tetracycline Powder
other · Food and Drug Administration · Rule · Published 2012-04-09 · Effective 2012-04-09 · 77 FR 20987
Document
Document number
2012-8322
Federal Register citation
77 FR 20987
CFR reference
21 CFR 520
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2012-04-09
Effective date
2012-04-09
HHS docket
Docket No. FDA-2012-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three abbreviated new animal drug applications (ANADAs) for lincomycin hydrochloride; penicillin G potassium, USP; and tetracycline hydrochloride soluble powders administered in drinking water from Teva Animal Health, Inc., to Quo Vademus, LLC.