[Federal Register Volume 66, Number 150 (Friday, August 3, 2001)]
[Notices]
[Page 40708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19463]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1638]


Alpharma, Inc.; Withdrawal of Approval of NADA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA) held by Alpharma, Inc. The NADA 
111-637 provides for use of tylosin Type A medicated articles to make 
Type C medicated swine, beef cattle, and chicken feeds. Alpharma, Inc., 
holds NADA 46-415 that also provides for use of tylosin Type A 
medicated articles to make Type C medicated swine, beef cattle, and 
chicken feeds. Therefore, this withdrawal of approval does not require 
amending the animal drug regulations.

EFFECTIVE DATE: August 13, 2001.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0159.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, is sponsor of NADA 111-637. The NADA provides 
for use of tylosin Type A medicated articles to make Type C medicated 
swine, beef cattle, and chicken feeds. The firm requested that approval 
of the NADA be withdrawn because the product is no longer manufactured 
or marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10), and further redelegated to the Center for 
Veterinary Medicine (21 CFR 5.84), and in accordance with 21 CFR 
514.115Withdrawal of approval of applications (21 CFR 514.115), notice 
is given that approval of NADA 111-637 and all supplements and 
amendments are withdrawn, effective August 13, 2001.
    Alpharma, Inc., holds NADA 46-415 that also provides for use of 
tylosin Type A medicated articles to make Type C medicated swine, beef 
cattle, and chicken feeds. Therefore, withdrawal of approval of NADA 
111-637 does not require amending the animal drug regulations in 21 CFR 
558.625(b)(54).

    Dated: July 6, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-19463 Filed 8-2-01; 8:45 am]
BILLING CODE 4160-01-F