[Federal Register Volume 59, Number 42 (Thursday, March 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4799]


[[Page Unknown]]

[Federal Register: March 3, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0021]

 

Schering-Plough Corp.; 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 Schering-Plough Corp. 
The NADA provides for the use of Variton (diphemanil methylsulfate) 
Cream 2 percent. The firm requested the withdrawal of approval.

EFFECTIVE DATE: March 14, 1994.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1623.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health, Schering-
Plough Corp., P.O. Box 529, Kenilworth, NJ 07033, is the sponsor of 
NADA 9-997 for Variton (diphemanil methylsulfate) Cream 2 percent for 
topical use on dogs and cats. By a letter dated November 15, 1993, 
Schering-Plough Corp. requested withdrawal of approval of the NADA 
because it no longer manufactures or distributes the product.

    Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10) and redelegated to the Center for Veterinary 
Medicine (21 CFR 5.84), and in accordance with
Sec. 514.115 Withdrawal of approval of applications (21 CFR 514.115), 
notice is given that approval of NADA 9-997 and all supplements and 
amendments thereto is hereby withdrawn, effective March 14, 1994.

    Dated: February 23, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine
[FR Doc. 94-4799 Filed 3-2-94; 8:45 am]
BILLING CODE 4160-01-F