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Elanco Animal Health, A Div. of Eli Lilly & Co. et al.; Withdrawal of Approval of NADAs

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of 13 new animal drug applications (NADAs) listed below at the request of the sponsor. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations by removing the portions reflecting approval of the NADAs.


Withdrawal of approval is effective May 14, 2001.

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Pamela K. Esposito, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-5593.

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The following sponsors have requested that FDA withdraw approval of the NADAs listed below because the products are no longer manufactured or marketed:

SponsorNADA Number Product (Drug)21 CFR Cite Affected (Sponsor Drug Labeler Code)
Elanco Animal Health, A Div. of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285NADA 12-585 Tylan Injectable (tylosin tartrate)522.2640b (000986)
NADA 15-207 Hyferdex Injection (iron dextran complex)522.1183(c) (000986)
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NADA 30-330 Tylocine Sulfa Tablets (sulfadiazine, sulfamerazine, sulfamethazine, tylosin)not applicable
NADA 31-962 Tylan plus Neomycin Eye Powder (neomycin sulfate, tylosin)524.2640 (000986)
NADA 40-123 Toptic Ointment (cephalonium, flumethasone, iodochlorhydroxyquin, piperocaine hydrochloride, polymyxin B sulfate)524.321 (000986)
NADA 47-092 Tribodine (ticarbodine)520.2460a (000986)
NADA 47-353 Ferti-Cept (chorionic gonadotropin)522.1081(b) (000986)
NADA 92-602 Cephalothin Discs (cephaloridine)529.360 (000986)
NADA 96-678 Tribodine Capsules (ticarbodine)520.2460b (000986)
Bioproducts, Inc., 320 Springside Dr., suite 300, Fairlawn, OH 44333-2435NADA 93-518 Tylan® 10 Plus (tylosin phosphate)558.625(b)(2) (051359)
Young’s Inc., Roaring Spring, PA 16673NADA 96-162 Hog Grow-R-Mix-4000, Hog Grow-R-Mix-800 (tylosin phosphate)558.625(b)(13) (035393)
Veterinary Laboratories, Inc., 12340 Santa Fe Dr., Lenexa, KS 66215NADA 42-889 Oxytocin Injection (oxytocin)522.1680(b) (000857)
Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363NADA 116-196 Webel Tylan Premix (tylosin phosphate)558.625(b)(73) (035098)

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 12-585, 15-207, 30-330, 31-962, 40-123, 42-889, 47-092, 47-353, 92-602, 93-518, 96-162, 96-678, and 116-196, and all supplements and amendments thereto, is hereby withdrawn, effective May 14, 2001.

In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations by removing those portions that reflect approval of the NADAs.

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Dated: April 23, 2001.

Linda Tollefson,

Deputy Director, Center for Veterinary Medicine.

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[FR Doc. 01-11071 Filed 5-2-01; 8:45 am]