[Federal Register Volume 62, Number 54 (Thursday, March 20, 1997)]
[Rules and Regulations]
[Page 13302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7002]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Animal Drugs, Feeds, and Related Products; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for two new animal drug 
applications (NADA's) from Biocraft Laboratories, Inc., to Teva 
Pharmaceuticals USA.

EFFECTIVE DATE: March 20, 1997.

FOR FURTHER INFORMATION CONTACT:  Thomas J. McKay, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION:  Biocraft Laboratories, Inc., 92 Route 46, 
Elmwood Park, NJ 07407, has informed FDA that it has transferred 
ownership of, and all rights and interests in, NADA's 65-492 
(amoxicillin trihydrate tablets) and 65-495 (amoxicillin trihydrate for 
oral suspension) to Teva Pharmaceuticals USA, 650 Cathill Rd., 
Sellersville, PA 18960. Accordingly, the agency is amending the 
regulations in 21 CFR 520.88b and 520.88f to reflect the transfer of 
ownership.

List of Subjects in 21 CFR Part 520

    Animal drugs.
    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:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

Sec. 520.88b   [Amended]

    2. Section 520.88b Amoxicillin trihydrate for oral suspension is 
amended in paragraph (c) by removing the number ``000332'' and adding 
in its place ``000093''.


Sec. 520.88f   [Amended]

    3. Section 520.88f Amoxicillin trihydrate tablets is amended in 
paragraph (b) by removing the number ``000332'' and adding in its place 
``000093''.

    Dated: March 11, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-7002 Filed 3-19-97; 8:45 am]
BILLING CODE 4160-01-F