66 FR 86 pgs. 22235-22236 - Elanco Animal Health, A Div. of Eli Lilly Co. et al.; Withdrawal of Approval of NADAs
Type: NOTICEVolume: 66Number: 86Pages: 22235 - 22236
Docket number: [Docket No. 01N-0183]
FR document: [FR Doc. 01-11071 Filed 5-2-01; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0183]
Elanco Animal Health, A Div. of Eli Lilly Co. et al.; Withdrawal of Approval of NADAs
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
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.
DATES:
Withdrawal of approval is effective May 14, 2001.
FOR FURTHER INFORMATION CONTACT:
Pamela K. Esposito, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-5593.
SUPPLEMENTARY INFORMATION:
The following sponsors have requested that FDA withdraw approval of the NADAs listed below because the products are no longer manufactured or marketed:
| Sponsor | NADA 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 46285 | NADA 12-585 Tylan Injectable (tylosin tartrate) | 522.2640b (000986) |
| NADA 15-207 Hyferdex Injection (iron dextran complex) | 522.1183(c) (000986) | |
| 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 44333-2435 | NADA 93-518 Tylan® 10 Plus (tylosin phosphate) | 558.625(b)(2) (051359) |
| Young's Inc., Roaring Spring, PA 16673 | NADA 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 66215 | NADA 42-889 Oxytocin Injection (oxytocin) | 522.1680(b) (000857) |
| Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363 | NADA 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.
Dated: April 23, 2001.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 01-11071 Filed 5-2-01; 8:45 am]
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