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Oral Dosage Form New Animal Drugs; Chlortetracycline Soluble Powder Concentrate

other · US Department of Health and Human Services · Rule · Published 1995-05-19 · Effective 1995-05-19 · 60 FR 26826

Document

Document number
95-12291
Federal Register citation
60 FR 26826
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1995-05-19
Effective date
1995-05-19

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 the American Cyanamid Co. The supplemental NADA provides for the safe and effective use of chlortetracycline bisulfate (CTC bisulfate) soluble powder concentrate in the drinking water of chickens and turkeys for control of certain bacterial diseases susceptible to CTC, in the drinking water of swine, and as a drench in cattle for control and treatment of certain bacterial diseases susceptible to CTC. The approved supplemental NADA reflects compliance with findings of the National Academy of Sciences/National Research Council (NAS/NRC), Drug Efficacy Study Group's (DESI) evaluation of related drug products' effectiveness and FDA's conclusions concerning that evaluation.

Source

Authoritative
Federal Register document
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