[Federal Register Volume 61, Number 155 (Friday, August 9, 1996)]
[Notices]
[Page 41635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20341]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0165]
Rhone Merieux, 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 Rhone Merieux, Inc. The
NADA provides for the use of Gallimycin (erythromycin)
Poultry Formula in poultry drinking water. The sponsor requested the
withdrawal of approval because the animal drug product is no longer
manufactured or marketed.
EFFECTIVE DATE: August 19, 1996.
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: Rhone Merieux, Inc., P.O. Box 459, 2116
Eighth Avenue South, Fort Dodge, IA 50501, is the sponsor of NADA 102-
656, which provides for the use of Gallimycin (erythromycin)
Poultry Formula in poultry drinking water. By letter of April 17, 1996,
Rhone Merieux, Inc., requested withdrawal of approval of the NADA
because the animal drug product is no longer manufactured or marketed.
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 102-656 and all supplements and amendments thereto is hereby
withdrawn, effective August 19, 1996.
Dated: July 17, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-20341 Filed 8-8-96; 8:45 am]
BILLING CODE 4160-01-F
