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Notice

Able Laboratories, Inc.; Withdrawal of Approval of 43 Abbreviated New Drug Applications

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Information about this document as published in the Federal Register.

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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 The drug products are no longer marketed, and Able Labs has requested that the approval of the applications be withdrawn.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.

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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.

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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
40-390Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 milligrams (mg)/325 mg/40 mg
40-394Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/500 mg/40 mg
40-402Phentermine Hydrochloride (HCl) Tablets USP, 37.5 mg
40-403Phentermine HCL Capsules USP, 30 mg (powder)
40-413Methocarbamol Tablets USP, 500 mg and 750 mg
40-421Carisoprodol Tablets USP, 350 mg
40-427Phentermine HCl Capsules USP, 30 mg (beads)
40-449Promethazine HCl Suppositories USP, 50 mg
40-464Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/325 mg and 10 mg/325 mg
40-469Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/750 mg
40-473Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg
40-474Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/650 mg
40-476Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/650 mg
40-477Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/500 mg
40-478Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/325 mg
40-483Bethanechol Chloride Tablets USP, 10 mg
40-485Bethanechol Chloride Tablets USP, 25 mg
40-490Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/500 mg
40-492Bethanechol Chloride Tablets USP, 5 mg
40-497Phentermine HCl Capsules USP, 15 mg
40-504Promethazine HCl Suppositories USP, 12.5 mg and 25 mg
40-509Bethanechol Chloride Tablets USP, 50 mg
40-529Methamphetamine HCl Tablets USP, 5 mg
40-539Theophylline Extended-Release Tablets, 600 mg
40-543Theophylline Extended-Release Tablets, 400 mg
40-546Theophylline Extended-Release Tablets, 450 mg
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40-548Theophylline Extended-Release Tablets, 300 mg
40-558Promethazine HCl Tablets USP, 12.5 mg, 25 mg, and 50 mg
40-559Hydroxyzine HCl Tablets USP, 10 mg
40-562Hydroxyzine HCl Tablets USP, 25 mg
40-563Hydroxyzine HCl Tablets USP, 50 mg
76-114Indomethacin Extended-Release Capsules USP, 75 mg
76-121Lithium Carbonate Capsules USP, 300 mg
76-382Lithium Carabonate Extended-Release Tablets USP, 300 mg
76-462Metronidazole Extended-Release Tablets, 750 mg
76-505Metronidazole Capsules, 375 mg
76-519Metronidazole Tablets USP, 250 mg and 500 mg
76-528Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg
76-544Naproxen Sodium Tablets USP, 275 mg and 550 mg
76-666Indomethacin Capsules USP, 25 mg and 50 mg
76-814Dextroamphetamine Sulfate Extended-Release Capsules, 5 mg, 10 mg, and 15 mg
76-823Lithium Carbonate Capsules USP, 150 mg, 300 mg, and 600 mg
76-907Atenolol 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.

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Dated: January 4, 2006.

Douglas C. Throckmorton,

Deputy Director, Center for Drug Evaluation and Research.

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[FR Doc. E6-506 Filed 1-18-06; 8:45 am]

BILLING CODE 4160-01-S