Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder
other · Food and Drug Administration · Rule · Published 1996-10-08 · Effective 1996-10-08 · 61 FR 52690
Document
Document number
96-25811
Federal Register citation
61 FR 52690
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1996-10-08
Effective date
1996-10-08
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The supplemental ANADA provides for an additional container size for the firm's oxytetracycline hydrochloride (OTC HCl) soluble powder. The drug product is administered orally in drinking water for either control or control and treatment of certain diseases of chickens, turkeys, swine, cattle, and sheep. In addition, the regulations are amended to specify the withdrawal period for use of medicated drinking water made from the subject sponsor's drug and to add certain warning statements required on the labeling.