Oral Dosage Form New Animal Drugs; Tetracycline Powder
other · Food and Drug Administration · Rule · Published 2010-03-18 · Effective 2010-03-18 · 75 FR 12981
Document
Document number
2010-5925
Federal Register citation
75 FR 12981
CFR reference
21 CFR 520
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2010-03-18
Effective date
2010-03-18
HHS docket
Docket No. FDA-2010-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Alpharma, Inc. The supplemental NADA provides for revised labeling for a 25 gram per pound concentration of tetracycline hydrochloride soluble powder used to make medicated drinking water for calves, swine, chickens, and turkeys for the treatment and control of various bacterial diseases.