Able Laboratories, Inc.; Withdrawal of Approval of 43 Abbreviated New Drug Applications, 3097-3098 [E6-506]
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[Federal Register Volume 71, Number 12 (Thursday, January 19, 2006)] [Notices] [Pages 3097-3098] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: E6-506] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0010] Able Laboratories, Inc.; Withdrawal of Approval of 43 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 43 abbreviated new drug applications (ANDAs) held by Able Laboratories, Inc. (Able Labs), One Able Dr., Cranbury, NJ 08512. The drug products are no longer marketed, and Able Labs has requested that the approval of the applications be withdrawn. DATES: Effective January 19, 2006. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The applications listed in the table in this document are no longer marketed, and Able Labs has requested that FDA withdraw approval of the applications. The company has also, by its request, waived its opportunity for a hearing. ------------------------------------------------------------------------ Application No. Drug ------------------------------------------------------------------------ 40-390 Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 milligrams (mg)/325 mg/40 mg ------------------------------------------------------------------------ 40-394 Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/500 mg/40 mg ------------------------------------------------------------------------ 40-402 Phentermine Hydrochloride (HCl) Tablets USP, 37.5 mg ------------------------------------------------------------------------ 40-403 Phentermine HCL Capsules USP, 30 mg (powder) ------------------------------------------------------------------------ 40-413 Methocarbamol Tablets USP, 500 mg and 750 mg ------------------------------------------------------------------------ 40-421 Carisoprodol Tablets USP, 350 mg ------------------------------------------------------------------------ 40-427 Phentermine HCl Capsules USP, 30 mg (beads) ------------------------------------------------------------------------ 40-449 Promethazine HCl Suppositories USP, 50 mg ------------------------------------------------------------------------ 40-464 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/325 mg and 10 mg/325 mg ------------------------------------------------------------------------ 40-469 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/750 mg ------------------------------------------------------------------------ 40-473 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg ------------------------------------------------------------------------ 40-474 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/650 mg ------------------------------------------------------------------------ 40-476 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/650 mg ------------------------------------------------------------------------ 40-477 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/500 mg ------------------------------------------------------------------------ 40-478 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/325 mg ------------------------------------------------------------------------ 40-483 Bethanechol Chloride Tablets USP, 10 mg ------------------------------------------------------------------------ 40-485 Bethanechol Chloride Tablets USP, 25 mg ------------------------------------------------------------------------ 40-490 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/500 mg ------------------------------------------------------------------------ 40-492 Bethanechol Chloride Tablets USP, 5 mg ------------------------------------------------------------------------ 40-497 Phentermine HCl Capsules USP, 15 mg ------------------------------------------------------------------------ 40-504 Promethazine HCl Suppositories USP, 12.5 mg and 25 mg ------------------------------------------------------------------------ 40-509 Bethanechol Chloride Tablets USP, 50 mg ------------------------------------------------------------------------ 40-529 Methamphetamine HCl Tablets USP, 5 mg ------------------------------------------------------------------------ 40-539 Theophylline Extended-Release Tablets, 600 mg ------------------------------------------------------------------------ 40-543 Theophylline Extended-Release Tablets, 400 mg ------------------------------------------------------------------------ 40-546 Theophylline Extended-Release Tablets, 450 mg ------------------------------------------------------------------------ [[Page 3098]] 40-548 Theophylline Extended-Release Tablets, 300 mg ------------------------------------------------------------------------ 40-558 Promethazine HCl Tablets USP, 12.5 mg, 25 mg, and 50 mg ------------------------------------------------------------------------ 40-559 Hydroxyzine HCl Tablets USP, 10 mg ------------------------------------------------------------------------ 40-562 Hydroxyzine HCl Tablets USP, 25 mg ------------------------------------------------------------------------ 40-563 Hydroxyzine HCl Tablets USP, 50 mg ------------------------------------------------------------------------ 76-114 Indomethacin Extended-Release Capsules USP, 75 mg ------------------------------------------------------------------------ 76-121 Lithium Carbonate Capsules USP, 300 mg ------------------------------------------------------------------------ 76-382 Lithium Carabonate Extended-Release Tablets USP, 300 mg ------------------------------------------------------------------------ 76-462 Metronidazole Extended-Release Tablets, 750 mg ------------------------------------------------------------------------ 76-505 Metronidazole Capsules, 375 mg ------------------------------------------------------------------------ 76-519 Metronidazole Tablets USP, 250 mg and 500 mg ------------------------------------------------------------------------ 76-528 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/325 mg/ 40 mg/30 mg ------------------------------------------------------------------------ 76-544 Naproxen Sodium Tablets USP, 275 mg and 550 mg ------------------------------------------------------------------------ 76-666 Indomethacin Capsules USP, 25 mg and 50 mg ------------------------------------------------------------------------ 76-814 Dextroamphetamine Sulfate Extended-Release Capsules, 5 mg, 10 mg, and 15 mg ------------------------------------------------------------------------ 76-823 Lithium Carbonate Capsules USP, 150 mg, 300 mg, and 600 mg ------------------------------------------------------------------------ 76-907 Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg ------------------------------------------------------------------------ Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner of Food and Drugs, approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective January 19, 2006. Dated: January 4, 2006. Douglas C. Throckmorton, Deputy Director, Center for Drug Evaluation and Research. [FR Doc. E6-506 Filed 1-18-06; 8:45 am] BILLING CODE 4160-01-S
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