[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
