[Federal Register Volume 71, Number 12 (Thursday, January 19, 2006)]
[Notices]
[Pages 3097-3098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-506]


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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.

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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the approval of the applications be withdrawn.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