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 The drug products are no longer marketed, and Able Labs has requested that the approval of the applications be withdrawn.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