Notices. Notice
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/register/2013/08/23/2013-20615·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0002] Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin 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) held by Quali-Tech Products, Inc., at the sponsor's request because the products are no longer manufactured or marketed. DATES: Withdrawal of approval is effective September 3, 2013. FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855; 240-453-6843; email: *david.alterman@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: Quali-Tech Products, Inc., has requested that FDA withdraw approval of the following four NADAs because the products, used to manufacture Type C medicated feeds, are no longer manufactured or marketed: NADA 097-980 for Quali-Tech TYLAN-10 (tylosin phosphate) Premix, NADA 118-815 for Q.T. BAN-TECH (pyrantel tartrate), NADA 132-705 for FLAVOMYCIN (bambermycins), and NADA 133-335 for STAFAC (virginiamycin) Swine Pak 10. 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that approval of NADAs 097-980, 118-815, 132-705, and 133-335, and all supplements and amendments thereto, is hereby withdrawn. Elsewhere in this issue of the **Federal Register** , FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications. Dated: August 20, 2013. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2013-20615 Filed 8-22-13; 8:45 am]
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