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Intramammary Dosage Forms; Change of Sponsor

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.


Final rule.


The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three approved new animal drug applications (NADAs) from Pfizer, Inc., to Schering-Plough Animal Health Corp.


This rule is effective July 31, 2003.

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David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail:

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Pfizer, Inc., 235 East 42d St., New York, NY 10017, has informed FDA that it has transferred ownership of, and all rights and interest in, the following three approved NADAs to Schering-Plough Animal Health Corp., 1095 Morris Ave., Union, NJ 07083:

NADA No.Trade Name
55-069ORBENIN DC (cloxacillin benzathine)
55-070DARICLOX (cloxacillin sodium)
55-100AMOXI-MAST (amoxicillin trihydrate)

Accordingly, the agency is amending the regulations in 21 CFR 526.88, 526.464b, and 526.464c to reflect the transfer of ownership.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

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List of Subjects in 21 CFR Part 526

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine,

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1. The authority citation for

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Authority: 21 U.S.C. 360b.

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2. Section 526.88

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3. Section 526.464b

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4. Section 526.464c

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Dated: July 18, 2003.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

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[FR Doc. 03-19445 Filed 7-30-03; 8:45 am]