70 FR 70 pg. 19488 - Withdrawal of Approval of a New Animal Drug Application; Dichlorophene and Toluene Capsules
Type: NOTICEVolume: 70Number: 70Page: 19488
Docket number: [Docket No. 2005N-0059]
FR document: [FR Doc. 05-7338 Filed 4-12-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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.
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of applications , notice is given that approval of NADA 121-557 and all supplements and amendments thereto, is hereby withdrawn, effective April 25, 2005.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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