[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Notices]
[Page 55810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22809]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0425]
Withdrawal of Approval of New Animal Drug Applications;
Chloramphenicol, Lincomycin, Pyrantel Tartrate, and Tylosin Phosphate
and Sulfamethazine
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of four new animal drug applications (NADAs). In a final rule published
elsewhere in this issue of the Federal Register, FDA is amending the
regulations to remove portions reflecting approval of these NADAs.
DATES: Withdrawal of approval is effective September 24, 2010.
FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9079, email: [email protected].
SUPPLEMENTARY INFORMATION: John J. Ferrante, 11 Fairway Lane, Trumbull,
CT 06611; International Nutrition, Inc., 7706 ``I'' Plaza, Omaha, NE
68127; and Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698,
Mankato, MN 56001 have requested that FDA withdraw approval of the four
NADAs listed in table 1 because they are no longer manufactured or
marketed:
Table 1.
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NADA Number Product 21 CFR Cite
Sponsor (Established Name of (Sponsor's Drug
Drug) Labeler Code)
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John J. Ferrante, 11 NADA 65-137 AMPHICOL-V Sec. 520.390b
Fairway Lane, Capsules (058034)
Trumbull, CT 06611 (chloramphenicol)
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International NADA 121-337 INI Swine Sec. 558.485
Nutrition, Inc., 7706 Ban-Wormer B-9.6 BA. (043733)
``I'' Plaza, Omaha, (pyrantel tartrate)
NE 68127
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International NADA 132-923 LINCO 8/ Sec. 558.325
Nutrition, Inc., 7706 LINCO 20 (lincomycin) (043733)
``I'' Plaza, Omaha,
NE 68127
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Feed Service Co., NADA 138-342 TYLAN 5 Sec. 558.630
Inc., 303 Lundin Sulfa-G Premix (tylosin (030841)
Blvd., P.O. Box 698, and sulfamethazine)
Mankato, MN 56001
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Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec. 514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of NADAs
65-137, 121-337, 132-923, and 138-342, and all supplements and
amendments thereto, is hereby withdrawn, effective September 24, 2010.
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 these NADAs.
Dated: September 1, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-22809 Filed 9-13-10; 8:45 am]
BILLING CODE 4160-01-S