[Federal Register: April 13, 2005 (Volume 70, Number 70)]
[Notices]               
[Page 19488]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ap05-129]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0059]

 
Withdrawal of Approval of a New Animal Drug Application; 
Dichlorophene and Toluene Capsules

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) for dichlorophene and 
toluene capsules used in dogs and cats for removal of certain 
intestinal parasites. In a final rule published elsewhere in this issue 
of the Federal Register, FDA is amending the animal drug regulations to 
remove portions reflecting approval of this NADA.

DATES:  Withdrawal of approval is effective April 25, 2005.

FOR FURTHER INFORMATION CONTACT:  Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-7818, e-mail: 
pesposit@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: Natchez Animal Supply Co., 201 John R. 
Junkin Dr., Natchez, MS 39120, has requested that FDA withdraw approval 
of NADA 121-557 for THR Worm (dichlorophene and toluene) Capsules used 
in dogs and cats for removal of certain intestinal parasites. This 
action is requested because the product is no longer manufactured or 
marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10), redelegated to the Center for Veterinary 
Medicine (21 CFR 5.84), and in accordance with 21 CFR 514.115 
Withdrawal of approval of applications, notice is given that approval 
of NADA 121-557 and all supplements and amendments thereto, is hereby 
withdrawn, effective April 25, 2005.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is amending the animal drug regulations to reflect the 
withdrawal of approval of this NADA.

    Dated: March 31, 2005.
Catherine P. Beck,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-7338 Filed 4-12-05; 8:45 am]

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