New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Lincomycin and Spectinomycin Soluble Powder; Sulfadimethoxine Oral Solution and Soluble Powder; Tiamulin
other · Food and Drug Administration · Rule · Published 2012-09-14 · Effective 2012-09-14 · 77 FR 56769
Document
Document number
2012-22646
Federal Register citation
77 FR 56769
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2012-09-14
Effective date
2012-09-14
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 three abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Phibro Animal Health Corp. FDA is also amending the regulations to reflect a change of sponsor's address for Phibro Animal Health Corp. and for Eka Chemicals, Inc.