[Federal Register Volume 59, Number 126 (Friday, July 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16093]


[[Page Unknown]]

[Federal Register: July 1, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

21 CFR Part 510

 

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 three new animal 
drug applications (NADA's) from Richlyn Laboratories, Inc., to Global 
Pharmaceutical Corp.

EFFECTIVE DATE: July 1, 1994.

FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1646.

SUPPLEMENTARY INFORMATION: Richlyn Laboratories, Inc., Castor and 
Kensington Aves., Philadelphia, PA 19124, has informed FDA that it has 
transferred ownership of, and all rights and interests in, approved 
NADA's 65-065 (Tetracycline Hydrochloride), 92-151 (N-Butyl Chloride 
Capsules, and 138-900 (Dichlorophene and Toluene Capsules) to Global 
Pharmaceutical Corp., Castor and Kensington Aves., Philadelphia, PA 
19124.
    Accordingly, the agency is amending the regulations in 21 CFR parts 
510.600(c)(1) and (c)(2) to reflect the change of sponsor. The drug 
labeler code assigned to Richlyn Laboratories, Inc., is being retained 
as the drug labeler code for Global Pharmaceutical Corp.

List of Subjects in 21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.
    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 510 is 
amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).


Sec. 510.600  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) by removing the entry for ``Richlyn Laboratories, Inc.'' and by 
alphabetically adding a new entry for ``Global Pharmaceutical Corp., 
Castor and Kensington Aves., Philadelphia, PA 19124 . . . . 000115'' 
and in the table in paragraph (c)(2) in the entry for ``000115'' by 
removing the sponsor name ``Richlyn Laboratories, Inc.'' and adding in 
its place ``Global Pharmaceutical Corp.''

    Dated: June 24, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-16093 Filed 6-30-94; 8:45 am]
BILLING CODE 4160-01-F