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Oral Dosage Form New Animal Drugs; 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 two approved new animal drug applications (NADAs) from Teva Pharmaceuticals USA to Delmarva Laboratories, Inc.


This rule is effective September 18, 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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Teva Pharmaceuticals USA, 650 Cathill Rd., Sellersville, PA 18960, has informed FDA that it has transferred ownership of, and all rights and interest in, the following two approved NADAs to Delmarva Laboratories, Inc., 1500 Huguenot Rd., suite 106, Midlothian, VA 23113:

NADA No.Trade Name
65-492ROBAMOX V (amoxicillin trihydrate) Tablets
65-495ROBAMOX V (amoxicillin trihydrate)

Accordingly, the agency is amending the regulations in 21 CFR 520.88b and 520.88f 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 520

  • Animal drugs
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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, 21 CFR part 520 is amended as follows:

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1. The authority citation for 21 CFR part 520 continues to read as follows:

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

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2. Section 520.88b Amoxicillin trihydrate for oral suspension is amended in paragraph (c) by removing “Sponsor. See Nos. 000093 and 000856” and by adding in its place “Sponsors. See Nos. 000856 and 059079”.

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3. Section 520.88f Amoxicillin trihydrate tablets is amended in paragraph (b) by removing “Sponsor. See Nos. 000093 and 000856” and by adding in its place “Sponsors. See Nos. 000856 and 059079”.

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Dated: August 28, 2003.

Steven D. Vaughn,

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

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[FR Doc. 03-23779 Filed 9-17-03; 8:45 am]