Notices. Notice
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/register/2005/08/26/05-16994·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0149] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is withdrawing approval of 16 new animal drug applications (NADAs) and 1 abbreviated NADA (ANADA) because the products are no longer manufactured or marketed. In a final rule published elsewhere in this issue of the **Federal Register** , FDA is amending the animal drug regulations to remove portions reflecting approval of the NADAs. DATES: Withdrawal of approval is effective September 6, 2005. FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-7818, or e-mail: *pesposit@cvm.fda.gov* . SUPPLEMENTARY INFORMATION: The following sponsors have requested that FDA withdraw approval of the 16 NADAs and 1 ANADA listed in table 1 of this document because the products are no longer manufactured or marketed: **Table 1.** Sponsor NADA Number, Product
(Drug)21 CFR Section Affected, (Sponsor Drug Labeler Code) Abbott Laboratories, North Chicago, IL 60064 NADA 99-568, FURANACE Caps (nifurpirinol) 529.1526 (000074) Biocraft Laboratories, Inc., 92 Route 46, Elmwood Park, NJ 07407 NADA 140-889, DERM-OTIC Ointment (neomycin sulfate, nystatin, thiostrepton, triamcinolone acetonide) 524.1600a (000332) First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123 NADA 48-646, THERAZONE Injection (phenylbutazone) 522.1720 (058829) Happy Jack, Inc., Snow Hill, NC 28580 NADA 121-556, Selenium Sulfide Suspension (selenium disulfide) 524.2101 (023851) NADA 121-723, Nitrofurazone Dressing 524.1580b (023851) NADA 125-137, FILARICIDE Capsules (diethylcarbamazine citrate) 520.622d (023851) IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544 NADA 92-151, N-Butyl Chloride Canine Worming Caps 520.260 (000115) NADA 65-065, Tetracycline HCl Caps 520.2345a (000115) NADA 138-900, Dichlorophene/Toluene 520.580 (000115) Jorgensen Laboratories, Inc., 1450 North Van Buren Ave., Loveland, CO 80538 NADA 10-481, SUREJETS (salacylic acid) 529.2090 (048087) Pliva d.d., Ulica grada Vukovara 49, 10000 Zagreb, Croatia ANADA, 200-232, GEOMYCIN 200 Injection (oxytetracycline) 522.1660a (011722) Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-6812 NADA 65-113 AUREO Sulfa Soluble Powder (chlortetracycline/sulfamethazine) N/A (017800) Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 07054-1298 NADA 140-848, VETEEZE Injection (diazepam) 522.575 (063238) Teva Pharmaceuticals USA, 650 Cathill Rd., Sellersville, PA 18960 NADA 131-806, Furosemide Tablets 520.1010 (000093) Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137 NADA 10-886, Purina Liquid Wormer (piperazine citrate) N/A (051311) Wyeth Laboratories, Division of American Home Products Corp., P.O. Box 8299, Philadelphia, PA 19101 NADA 10-782, SPARINE Injection (promazine) 522.1962 (000008) NADA 55-008, BICILLIN Fortified (penicillin G benzathine and penicillin G procaine) 522.1696a (000008) Therefore, under authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10), redelegated to the Center for Veterinary Medicine (21 CFR 5.84), and in accordance with § 514.115 *Withdrawal of approval of applications* (21 CFR 514.115), notice is given that approval of NADAs 10-481, 10-782, 10-886, 48-646, 55-008, 65-065, 65-113, 99-568, 121-556, 121-723, 125-137, 131-806, 138-900, 140-848, 140-889, and ANADA 200-232, and all supplements and amendments thereto, is hereby withdrawn, effective September 6, 2005. 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: July 5, 2005. Linda Tollefson, Acting Director, Center for Veterinary Medicine. [FR Doc. 05-16994 Filed 8-25-05; 8:45 am]
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- 21 CFR 5.10
- 21 CFR 5.84
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