Oral Dosage Form New Animal Drugs; Change of Sponsor; Griseofulvin Powder; Levamisole Hydrochloride Powder; Oxytetracycline Powder
other · Food and Drug Administration · Rule · Published 2012-05-14 · Effective 2012-05-14 · 77 FR 28252
Document
Document number
2012-11382
Federal Register citation
77 FR 28252
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2012-05-14
Effective date
2012-05-14
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 five abbreviated new animal drug applications (ANADAs) for griseofulvin powder, levamisole hydrochloride soluble powder, and oxytetracycline hydrochloride soluble powder from Teva Animal Health, Inc., to Cross Vetpharm Group, Ltd.