[Federal Register Volume 63, Number 21 (Monday, February 2, 1998)]
[Notices]
[Page 5386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2408]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0507]
Mountaire Vitamins, Inc., et al.; Withdrawal of Approval of
NADA's
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of eight new animal drug applications (NADA's) as requested by the
sponsors. The NADA's provide for use of products that are no longer
made or marketed. In a final rule published elsewhere in this issue of
the Federal Register, FDA is amending the regulations by removing the
entries that reflect approval of the NADA's.
EFFECTIVE DATE: February 12, 1998.
FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1722.
SUPPLEMENTARY INFORMATION: The following sponsors have requested
withdrawal of approval of NADA's that provide for use of the animal
drug products noted:
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Sponsor name and
NADA No. Drug name address
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38-247........................ Hygromycin B Type A Mountaire Feeds,
medicated article. Inc., 124 East
Fifth, P.O. Box
5391, North Little
Rock, AR 72119,
formerly Mountaire
Vitamins, Inc.,
400 North Poplar
St., P.O. Box
9210, North Little
Rock, AR 72119
44-013........................ Tylosin Type A do.
medicated article.
65-273........................ Chloramphenicol Zenith Goldline
capsules, USP. Pharmaceuticals,
Inc., 140 Legrand
Ave., Northvale,
NJ 07647, formerly
Zenith
Laboratories,
Inc., 50 Williams
Dr., Ramsey, NJ
07446
65-456........................ Tetracycline HCl do.
capsules, USP.
95-736........................ Hygromycin B Type A Mountaire Feeds,
medicated article. Inc.
98-895........................ Starbar GX-118 Wellmark
Topical International,
(phosmet)(prolate). 1000 Tower Lane,
Bensenville, IL
60106, formerly
Sandoz Agro, Inc.,
1300 East Touhy
Ave., Des Plaines,
IL 60018
137-138....................... Pyrantel tartrate Mountaire Feeds,
Type A medicated Inc.
article.
139-239....................... Banminth (pyrantel Growmark, Inc., 950
tartrate) Type A North Meridian
medicated article. St., Indianapolis,
IN 46204-3909,
formerly at 1701
Towanda Ave.,
Bloomington, IL
61701
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The sponsors are requesting withdrawal of approval of the NADA's
because the products approved under the NADA's are no longer made 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's 38-247, 44-013, 65-273, 65-456, 95-736, 98-895, 137-
138, and 139-239, and all supplements and amendments thereto is hereby
withdrawn, effective February 12, 1998.
In a final rule published elsewhere in this issue of the Federal
Register, FDA is amending 21 CFR 510.600, 520.390b, 520.2345a,
524.1742, 558.274, 558.485, and 558.625 to reflect the withdrawal of
approval of these NADA's.
Dated: January 8, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-2408 Filed 1-30-98; 8:45 am]
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