[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
