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New Animal Drugs for Use in Animal Feeds; Oxytetracycline Type A Medicated Articles

other · US Department of Health and Human Services · Rule · Published 1996-10-03 · 61 FR 51588

Document

Document number
96-25257
Federal Register citation
61 FR 51588
CFR reference
21 CFR 558
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1996-10-03

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 Pfizer, Inc. The supplemental NADA provides revised labeling for Pfizer's pioneer, Type A, oxytetracycline- containing, medicated articles which brings the products into compliance with the findings of the National Academy of Sciences/ National Research Council (NAS/NRC), Drug Efficacy Study Group's (DESI) effectiveness evaluation and subsequent FDA conclusions. In addition, the regulations are further amended to reflect approval, based on FDA's DESI ``me-too'' policy, of one original NADA each filed by Pfizer and PennField Oil Co. for Type A medicated articles that are copies of the Pfizer pioneer products.

Source

Authoritative
Federal Register document
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