Notices. Notice
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/register/2010/09/14/2010-22809·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4140-01-P 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. 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: *john.bartkowiak@fda.hhs.gov* . 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. Sponsor NADA Number Product (Established Name of Drug) 21 CFR Cite (Sponsor's Drug Labeler Code) John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611 NADA 65-137 AMPHICOL-V Capsules (chloramphenicol) § 520.390b (058034) International Nutrition, Inc., 7706 “I” Plaza, Omaha, NE 68127 NADA 121-337 INI Swine Ban-Wormer B-9.6 BA. (pyrantel tartrate) § 558.485 (043733) International Nutrition, Inc., 7706 “I” Plaza, Omaha, NE 68127 NADA 132-923 LINCO 8/LINCO 20 (lincomycin) § 558.325 (043733) Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698, Mankato, MN 56001 NADA 138-342 TYLAN 5 Sulfa-G Premix (tylosin and sulfamethazine) § 558.630 (030841) Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 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that approval of NADAs 65-137, 121-337, 132-923, and 138-342, and all supplements and amendments thereto, is hereby withdrawn, effective September 24, 2010.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]
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