[Federal Register Volume 72, Number 215 (Wednesday, November 7, 2007)]
[Notices]
[Pages 62858-62863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21886]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0427]


Lederle Laboratories et al.; Withdrawal of Approval of 73 New 
Drug Applications and 62 Abbreviated New Drug Applications

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is withdrawing 
approval of 73 new drug applications (NDAs) and 62 abbreviated new drug 
applications (ANDAs) from multiple applicants. The holders of the 
applications notified the agency in writing that the drug products were 
no longer marketed and requested that the approval of the applications 
be withdrawn.
EFFECTIVE DATE: December 7, 2007.

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 holders of the applications listed in 
the table in this document have informed FDA that these drug products 
are no longer marketed and have requested that FDA withdraw approval of 
the applications. The applicants have also, by their requests, waived 
their opportunity for a hearing.

------------------------------------------------------------------------
 Application No.              Drug                     Applicant
------------------------------------------------------------------------
NDA 6-459          Hetrazan                    Lederle Laboratories, c/o
                    (diethylcarbamaxine         Wyeth Pharmaceuticals,
                    citrate) Tablets and        Inc., P.O. Box 8299,
                    Syrup                       Philadelphia, PA 19101-
                                                8299
------------------------------------------------------------------------
NDA 6-799          Rubramin and Rubramin PC    Bristol-Myers Squibb Co.,
                    (cyanocobalamin injection   P.O. Box 4000,
                    USP)                        Princeton, NJ 08543-4000
------------------------------------------------------------------------
NDA 7-517          Tapazole (methimazole       King Pharmaceuticals,
                    tablets USP), 5             Inc., 501 Fifth St.,
                    milligrams (mg) and 10 mg   Bristol, TN 37620
------------------------------------------------------------------------
NDA 7-942          Sus-Phrine (epinephrine)    Forest Laboratories,
                    Injection                   Inc., Harborside
                                                Financial Center, Plaza
                                                Three, suite 602, Jersey
                                                City, NJ 07311
------------------------------------------------------------------------
NDA 9-319          Ambenyl Expectorant and     Do.
                    Ambenyl Cough Syrup
------------------------------------------------------------------------
NDA l0-533         PBZ SR (tripelennamine HCl  Novartis Pharmaceuticals
                    USP) Extended-Release       Corp., One Health Plaza,
                    Tablets                     East Hanover, NJ 07936-
                                                1080
------------------------------------------------------------------------
NDA 10-744         Darbid (isopropamide        SmithKline Beecham Corp.,
                    iodide) Tablets             d/b/a/ GlaxoSmith Kline,
                                                P.O. Box 13398, Five
                                                Moore Dr., Research
                                                Triangle Park, NC 27709
------------------------------------------------------------------------
NDA 10-909         Miradon (anisindione)       Schering Corp., 2000
                    Tablets                     Galloping Hill Rd.,
                                                Kenilworth, NJ 07033
------------------------------------------------------------------------
NDA 11-213         Trilafon (perphenazine)     Do.
                    Injection, 5 mg/
                    milliliter (mL)
------------------------------------------------------------------------
NDA 11-283         Kenacort (tramcinolone)     Bristol-Myers Squibb Co.
                    Tablets
------------------------------------------------------------------------
NDA 11-808         Mellaril (thioridazine      Novartis Pharmaceuticals
                    HCl) Tablets                Corp.
------------------------------------------------------------------------
NDA 12-145         Prolixin (fluphenazine      Apothecon, c/o Bristol-
                    HCl) Elixir, 0.5 mg/mL      Myers Squibb Co., P.O.
                                                Box 4500, Princeton, NJ
                                                08543-4500
------------------------------------------------------------------------
NDA 12-313         BIO-CLEAR                   Helena Rubinstein, 202
                    (dibenzothiophene) Cream    Rodney Bldg., 3411
                                                Silverside Rd.,
                                                Wilmington, DE 19810
------------------------------------------------------------------------
NDA 12-665         Velban (vinblastine         Eli Lilly and Co., Lilly
                    sulfate) for Injection      Corporate Center,
                                                Indianapolis, IN 46285
------------------------------------------------------------------------
NDA 12-678         Tolbutamide Tablets         Sandoz Inc., 227-15 North
                                                Conduit Ave., Laurelton,
                                                NY 11413
------------------------------------------------------------------------
NDA 12-796         Quinidex Extentabs          Wyeth Pharmaceuticals,
                    (quinidine sulfate          Inc.
                    extended-release tablets
                    USP)
------------------------------------------------------------------------
NDA 14-103         Oncovin (vincristine        Eli Lilly and Co.
                    sulfate) Injection
------------------------------------------------------------------------
NDA 14-242         Dexacort (dexamethasone     UCB, 755 Jefferson Rd.,
                    sodium phosphate)           Rochester, NY 14623
                    Turbinaire
------------------------------------------------------------------------

[[Page 62859]]

 
NDA 14-262         Solbar (dioxybenzone and    Person & Covey, Inc., 616
                    oxybenzone) Cream           Allen Ave., Glendale, CA
                                                91201
------------------------------------------------------------------------
NDA 16-363         Lasix (furosemide) 10-mg/   Sanofi-Aventis, 300
                    mL Injection                Somerset Corporate
                                                Blvd., Bridgewater, NJ
                                                08807-0977
------------------------------------------------------------------------
NDA 16-408         WILDROOT (pyrithione zinc)  Colgate-Palmolive Co.,
                    Hair Groom and Grenadier    909 River Rd.,
                    Hair Groom                  Piscataway, NJ 08854-
                                                5596
------------------------------------------------------------------------
NDA 16-729         Ferrous Citrate Fe 59       Mallinckrodt Inc., 675
                    Injection                   McDowell Blvd., P.O. Box
                                                5840, St. Louis, MO
                                                63134
------------------------------------------------------------------------
NDA 16-820         Emete-Con (benzquinamide    Pfizer, Inc., 235 East
                    HCl) Injection              42nd St., New York, NY
                                                10017
------------------------------------------------------------------------
NDA 16-847         Isopaque 440 (metrizoate    GE Healthcare, 101
                    sodium, meglumine           Carnegie Center,
                    metrizoate, calcium         Princeton, NJ 08540
                    metrizoate, and
                    metrizoate magnesium)
                    Injection
------------------------------------------------------------------------
NDA 17-430         Neggram (nalidixic acid     Sanofi-Aventis
                    USP) Suspension
------------------------------------------------------------------------
NDA 17-466         Bricanyl (terbutaline       Sanofi-Aventis
                    sulfate) Injection
------------------------------------------------------------------------
NDA 17-506         Isopaque 280 (metrizoic     GE Healthcare
                    acid, meglumine, and
                    calcium) Injection
------------------------------------------------------------------------
NDA 17-613         Lotrimin (clotrimazole)     Schering Corp.
                    Topical Solution, 1%
------------------------------------------------------------------------
NDA 17-618         Bricanyl (terbutaline       Sanofi-Aventis
                    sulfate) Tablets
------------------------------------------------------------------------
NDA 17-619         Lotrimin (clotrimazole)     Schering Corp.
                    Cream, 1%
------------------------------------------------------------------------
NDA 17-668         Tenuate (diethylpropion     Sanofi-Aventis
                    HCl) Tablets, 25 mg
------------------------------------------------------------------------
NDA 17-669         Tenuate (diethylpropion     Sanofi-Aventis
                    HCl) Extended-Release
                    Tablets, 75 mg
------------------------------------------------------------------------
NDA 17-688         Lasix (furosemide) Oral     Sanofi-Aventis
                    Solution, 10 mg/mL
------------------------------------------------------------------------
NDA 17-719         Dimeray (iocarmate          Mallinckrodt Inc.
                    meglumine) Injection
------------------------------------------------------------------------
NDA 17-725         Sodium Pertechnetate Tc-    Mallinckrodt Inc.
                    99m (technectium Tc-99m
                    sodium pertechnetate)
------------------------------------------------------------------------
NDA 17-730         Isopaque 370 (metrizoic     GE Healthcare
                    acid and meglume)
                    Injection
------------------------------------------------------------------------
NDA 17-769         Calcimar (calcitonin        Sanofi-Aventis
                    salmon) Injection
------------------------------------------------------------------------
NDA 17-838         Lungaggregate Reagent       GE Healthcare
------------------------------------------------------------------------
NDA 17-848         Tc-99m Lungaggregate        Do.
------------------------------------------------------------------------
NDA 17-907         Glucoscan Kit for the       Bristol-Myers Squibb
                    Preparation of Technetium   Pharma Co., Chestnut Run
                    Tc-99m Gluceptate           Plaza, 974 Centre Rd.,
                                                Wilmington, DE 19805
------------------------------------------------------------------------
NDA 17-923         Mellaril-S (thioridazine    Novartis Pharmaceuticals
                    HCl) Oral Suspension        Corp.
------------------------------------------------------------------------
NDA 17-956         Tepanil (diethylpropion     3M Pharmaceuticals, 3M
                    HCl) Ten-Tabs               Center, Bldg 0275-05-W-
                                                12, St. Paul, MN 55144-
                                                1000
------------------------------------------------------------------------
NDA 18-000         Bricanyl (terbutaline       Sanofi-Aventis
                    sulfate) Inhaler
------------------------------------------------------------------------
NDA 18-067         Cinobac (cinoxacin)         Eli Lilly and Co.
                    Capsules, 250 mg and 500
                    mg
------------------------------------------------------------------------
NDA 18-088         Krypton Kr-81m Gas          GE Healthcare
                    Generator
------------------------------------------------------------------------
NDA 18-148         Nasalide (flunisolide)      IVAX Research, Inc., 4400
                    Nasal Spray                 Biscayne Blvd., Miami,
                                                FL 33137
------------------------------------------------------------------------
NDA 18-489         Technescan HIDA (kit for    Draximage, 16751
                    the preparation of          Autoroute TransCanada
                    technetium Tc-99m           Highway, Kirkland,
                    lidofenin injection)        Quebec, H9H 4J4, Canada
------------------------------------------------------------------------
NDA 18-519         Irrigation Solution G       Baxter Healthcare Corp.,
                    (citric acid and sodium     1620 Waukegan Rd., MPGR-
                    carbonate)                  AL, McGaw Park, IL 60085
------------------------------------------------------------------------
NDA 18-554         Eulexin (flutamide)         Schering Corp.
                    Capsules
------------------------------------------------------------------------

[[Page 62860]]

 
NDA 18-700         Inocor (inamrinone          Sanofi-Synthelabo Inc., c/
                    lactate) Injection, 5 mg    o Sanofi-Aventis, 300
                    base/mL                     Somerset Corporate
                                                Blvd., P.O. Box 6977,
                                                Bridgewater, NJ 08807-
                                                0977
------------------------------------------------------------------------
NDA 18-770         Tornalate (bitolterol       Sanofi-Aventis
                    mesylate) Metered-Dose
                    Inhaler
------------------------------------------------------------------------
NDA 18-813         Lotrimin (clotrimazole)     Schering Corp.
                    Lotion, 1%
------------------------------------------------------------------------
ANDA 18-862        Betatrex (betamethasone     Savage Laboratories, 60
                    valerate cream USP, 0.1%)   Baylis Rd., Melville, NY
                                                11747
------------------------------------------------------------------------
ANDA 18-863        Betatrex (betamethasone     Do.
                    valerate ointment USP,
                    0.1%)
------------------------------------------------------------------------
ANDA 18-867        Betatrex (betamethasone     Do.
                    valerate lotion USP,
                    0.1%)
------------------------------------------------------------------------
NDA 19-084         Nizoral (ketoconazole)      Johnson & Johnson
                    Cream, 2%                   Pharmaceutical Research
                                                & Development, LLC, c/o
                                                Janssen Pharmaceutical
                                                Products, LP, 1125
                                                Trenton-Harbourton Rd.,
                                                P.O. Box 200,
                                                Titusville, NJ 08560
------------------------------------------------------------------------
NDA 19-284         Oral Colonic Lavage (OCL)   Hospira, Inc., 275 North
                    (sodium chloride, sodium    Field Dr., Bldg. 2-J45-
                    bicarbonate, sodium         2, Lake Forest, Il 60045-
                    sulfate, potassium          5046
                    chloride, and
                    polyethelene glycol 3350)
------------------------------------------------------------------------
NDA 19-408         Diprolene (betamethasone    Schering Corp.
                    dipropionate)
------------------------------------------------------------------------
NDA 19-459         Photoplex (7% padimate O    Allergan, 2525 Dupont
                    and 3% avobenzone) Lotion   Dr., P.O. Box 19534,
                                                Irvine, CA 92623-9534
------------------------------------------------------------------------
NDA 19-520         Travasol (amino acid) in    Baxter Healthcare Corp.
                    Dextrose Injection
------------------------------------------------------------------------
NDA 19-545         Didronel (etidronate        MGI Pharma, Inc., 5775
                    disodium) Injection         West Old Shakopee Rd.,
                                                suite 100, Bloomington,
                                                MN 55437-3174
------------------------------------------------------------------------
NDA 19-548         Tornalate (bitolterol       Sanofi-Aventis
                    mesylate) Inhalatioon
                    Solution, 0.2%
------------------------------------------------------------------------
NDA 19-576         Nizoral (ketoconazole)      Johnson & Johnson
                    Cream, 2%                   Pharmaceutical &
                                                Development, LLC
------------------------------------------------------------------------
NDA 19-648         Nizoral (ketoconazole)      Do.
                    Cream, 2%
------------------------------------------------------------------------
NDA 20-091         Imagent (perflubron)        Alliance Pharmaceuticals
                                                Corp., 4660 La Jolla
                                                Dr., suite 740, San
                                                Diego, CA 92122
------------------------------------------------------------------------
NDA 20-147         Travasol (amino acid) with  Baxter Healthcare Corp.
                    Electrolytes in Dextrose
                    Injection
------------------------------------------------------------------------
NDA 20-228         Atrovent (ipratropium       Boehringer Ingelheim
                    bromide) Inhalation         Pharmaceuticals, Inc.,
                    Solution                    900 Ridgebury Rd., P.O.
                                                Box 368, Ridgefield, CT
                                                06877-0368
------------------------------------------------------------------------
NDA 20-303         Prempro/Premphase           Wyeth Pharmaceuticals,
                    (conjugated estrogens and   Inc.
                    medroxyprogesterone
                    acetate) Tablets
------------------------------------------------------------------------
NDA 20-315         Orlaam (levomethadyl        Roxane Laboratories, P.O.
                    acetate HCl) Oral           Box 16532, Columbus, OH
                    Solution                    43216-6532
------------------------------------------------------------------------
NDA 20-486         Vanceril (beclomethasone    Schering Corp.
                    dipropionate) Double
                    Strength Aerosol
------------------------------------------------------------------------
NDA 20-887         AcuTect Kit for the         CIS-US, Inc., 10 De
                    Preparation of Technetium   Angelo Dr., Bedford, MA
                    Tc-99m Apticide Injection   01730
------------------------------------------------------------------------
NDA 21-012         Neo-Tect Kit for the        Do.
                    Preparation of Technetium
                    Tc-99m Depreotide
                    Injection
------------------------------------------------------------------------
NDA 21-075         Nutropin Depot (somatropin  Genentech Inc., 1 DNA Way
                    recombinant)                MS242, South
                                                San Francisco, CA 94080-
                                                4990
------------------------------------------------------------------------
ANDA 40-098        Acetaminophen and Codeine   Clonmel Healthcare, Ltd.,
                    Phosphate Oral Solution     c/o STADA
                    USP                         Pharmaceuticals Inc.,
                                                U.S. Agent, 5 Cedar
                                                Brook Dr., Cranbury, NJ
                                                08512
------------------------------------------------------------------------
NDA 50-477         Nebcin (tobramycin          Eli Lilly and Co.
                    sulfate) for Injection
------------------------------------------------------------------------
NDA 50-519         Nebcin (tobramycin          Do.
                    sulfate) for Injection
------------------------------------------------------------------------

[[Page 62861]]

 
NDA 50-678         Dynabac (dirithromycin      Lilly Research
                    delayed-release tablets     Laboratories, Lilly
                    USP)                        Corporate Center,
                                                Indianapolis, IN 46285
------------------------------------------------------------------------
ANDA 60-212        Grisactin (griseofulvin     Wyeth Ayerst
                    microcrystalline)           Laboratories, c/o Wyeth
                    Tablets, 500 mg             Pharmaceuticals, P.O.
                                                Box 8299, Philadelphia,
                                                PA 19101
------------------------------------------------------------------------
ANDA 60-570        Fungizone (amphotericin B   Apothecon, c/o Bristol-
                    lotion USP), 3%             Myers Squibb Co.
------------------------------------------------------------------------
ANDA 60-751        NEO-CORTEF (neomycin        Pharmacia & Upjohn Co., c/
                    sulfate and                 o Pfizer, Inc., 235 East
                    hydrocortisone acetate)     42nd St., New York, NY
                    Ointment                    10017
------------------------------------------------------------------------
ANDA 61-007        Terramycin                  Pfizer, Inc.
                    (oxytetracycline HCl,
                    polymyxin B sulfate)
                    Topical Ointment with
                    Polymyxin B Sulfate
------------------------------------------------------------------------
ANDA 61-131        Nystatin Powder USP         Clonmel Healthcare, Ltd.,
                                                c/o STADA
                                                Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 61-411        Veetids (penicillin V       Apothecon, c/o Bristol-
                    potassium tablets USP),     Myers Squibb Co.
                    250 mg and 500 mg
------------------------------------------------------------------------
ANDA 61-737        ZIBA-Rx (bacitracin zinc    X-GEN Pharmaceuticals,
                    USP)                        Inc., P.O. Box 1148,
                                                Elmira, NY 14902
------------------------------------------------------------------------
ANDA 61-859        Anspor (cephradine)         GlaxoSmithKline, One
                    Capsules, 250 mg and 500    Franklin Plaza, P.O. Box
                    mg                          7929, Philadelphia, PA
                                                19101-7929
------------------------------------------------------------------------
ANDA 61-866        Anspor (cephradine) for     Do.
                    Oral Suspension
------------------------------------------------------------------------
ANDA 61-876        Cerubidine Injection        Sanofi-Aventis
                    (daunorubice HCl for
                    injection USP)
------------------------------------------------------------------------
ANDA 62-519        Nystex (nystatin) Oral      Savage Laboratories
                    Suspension USP, 100,000
                    units/mL
------------------------------------------------------------------------
ANDA 62-560        Mandol (cefamadole nafate   Eli Lilly and Co.
                    for injection USP)
------------------------------------------------------------------------
ANDA 62-739        Tazidime (ceftazidime)      Do.
------------------------------------------------------------------------
ANDA 62-745        Cephalexin Tablets USP      Do.
------------------------------------------------------------------------
ANDA 62-888        Principen (ampicillin       Apothecon, c/o Bristol-
                    capsules USP), 250 mg and   Myers Squibb Co.
                    500 mg
------------------------------------------------------------------------
ANDA 62-926        Rubex (doxorubicin HCl for  Bristol-Myers Squibb Co.
                    injection USP)
------------------------------------------------------------------------
ANDA 63-021        Kanamycin Sulfate           Loch Pharmaceuticals, c/o
                    Injection USP, 75 mg/2 mL   Bedford Laboratories, A
                                                Division of Ben Venue
                                                Laboratories, Inc., 300
                                                Northfield Rd., Bedford,
                                                OH 44146
------------------------------------------------------------------------
ANDA 63-022        Kanamycin Sulfate           Do.
                    Injection USP, 500 mg/2
                    mL
------------------------------------------------------------------------
ANDA 63-025        Kanamycin Sulfate           Do.
                    Injection USP, 1 gram (g)/
                    3 mL
------------------------------------------------------------------------
ANDA 63-099        Trimox (amoxicillin         Apothecon, c/o Bristol-
                    capsules USP), 250 mg and   Myers Squibb Co.
                    500 mg
------------------------------------------------------------------------
ANDA 70-867        Vincrex (vincristine        Bristol-Myers Squibb Co.
                    sulfate for injection
                    USP), 5 mg/vial
------------------------------------------------------------------------
ANDA 71-742        Clorazepate Dipotassium     Clonmel Healthcare, Ltd.,
                    Capsules, 3.75 mg           c/o STADA
                                                Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 71-743        Clorazepate Dipotassium     Do.
                    Capsules, 7.5 mg
------------------------------------------------------------------------
ANDA 71-744        Clorazepate Dipotassium     Do.
                    Capsules, 15 mg
------------------------------------------------------------------------
ANDA 72-326        Fenoprofen Calcium Tablets  Do.
                    USP, 600 mg
------------------------------------------------------------------------
ANDA 72-507        Methyldopa and              Do.
                    Hydrochlorothiazide
                    Tablets USP, 250 mg/15 mg
------------------------------------------------------------------------
ANDA 72-508        Methyldopa and              Do.
                    Hydrochlorothiazide
                    Tablets USP, 250 mg/25 mg
------------------------------------------------------------------------
ANDA 72-509        Methyldopa and              Do.
                    Hydrochlorothiazide
                    Tables USP, 500 mg/30 mg
------------------------------------------------------------------------
ANDA 72-510        Methyldopa and              Do.
                    Hydrochlorothiazide
                    Tablets USP, 500 mg/50 mg
------------------------------------------------------------------------

[[Page 62862]]

 
ANDA 72-705        Prazosin HCl Capsules USP,  Do.
                    1 mg
------------------------------------------------------------------------
ANDA 72-706        Prazosin HCl Capsules USP,  Do.
                    2 mg
------------------------------------------------------------------------
ANDA 72-707        Prazosin HCL Capsules USP,  Do.
                    5 mg
------------------------------------------------------------------------
ANDA 74-258        Metoprolol Tartrate         Apothecon, c/o Bristol-
                    Tablets USP, 50 mg and      Myers Squibb Co.
                    100 mg
------------------------------------------------------------------------
ANDA 74-423        Captopril Tablets USP,      Clonmel Healthcare, Ltd.,
                    12.5 mg, 25 mg, 50 mg,      c/o of STADA
                    and 100 mg                  Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 74-472        Captopril Tablets USP,      Apothecon, c/o Bristol-
                    12.5 mg, 25 mg, 50 mg,      Myers Squibb Co.
                    and 100 mg
------------------------------------------------------------------------
ANDA 75-407        Morphine Sulfate Extended-  Clonmel Healthcare, Ltd.,
                    Release Tablets USP, 15     c/o STADA
                    mg                          Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 80-745        Aristocort (triamcinolone   Astellas Pharma US, Inc.,
                    acetonide) Ointment, 0.5%   Three Parkway North,
                                                Deerfield, IL 60015-2537
------------------------------------------------------------------------
ANDA 80-750        Aristocort (triamcinolone   Do.
                    acetonide) Ointment, 0.1%
------------------------------------------------------------------------
ANDA 83-015        Aristocort (triamcinolone   Do.
                    acetonide) Cream, 0.5%
------------------------------------------------------------------------
ANDA 83-016        Aristocort (triamcinolone   Do.
                    acetonide) Cream, 0.1%
------------------------------------------------------------------------
ANDA 83-017        Aristocort (triamcinolone   Do.
                    acetonide) Cream, 0.025%
------------------------------------------------------------------------
ANDA 83-149        PBZ (tripelennamine HCl)    Novartis Pharmaceuticals
                    Tablet, 25 mg               Corp., 59 Route 10, East
                                                Hanover, NJ 07936-1080
------------------------------------------------------------------------
ANDA 83-317        Propoxyphene HCl Capsules,  Impax Laboratories, Inc.,
                    65 mg                       30831 Huntwood Ave.,
                                                Hayward, CA 94544
------------------------------------------------------------------------
ANDA 83-380        Aristogel (triamcinolone    Astellas Pharma US, Inc.
                    acetonide) Gel, 0.1%
------------------------------------------------------------------------
ANDA 83-881        Aristocort A                Do.
                    (triamcinolone acetonide)
                    Spray
------------------------------------------------------------------------
ANDA 86-212        Chlordiazepoxide HCl        Impax Laboratories, Inc.
                    Capsules, 25 mg
------------------------------------------------------------------------
ANDA 86-213        Chlordiazepoxide Capsules,  Do.
                    5 mg
------------------------------------------------------------------------
ANDA 86-358        Mexate (methotrexate        Bristol-Myers Squibb Co.
                    sodium for injection)
------------------------------------------------------------------------
ANDA 86-926        Tolbutamide Tablets USP,    Clonmel Healthcare, Ltd.,
                    500 mg                      c/o STADA
                                                Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 87-011        Quinidine Sulfate Tablets   Do.
                    USP, 200 mg
------------------------------------------------------------------------
ANDA 87-677        Hydrocodone Bitartrate and  B.F. Ascher & Co., Inc.,
                    Acetaminophen               15501 West 109th St.,
                                                Lenexa, KS 66219
------------------------------------------------------------------------
ANDA 87-887        TRYSUL (triple sulfa        Savage Laboratories
                    vaginal cream USP)
------------------------------------------------------------------------
ANDA 88-584        DHC Plus (dihydrocodeine    The Purdue Frederick Co.,
                    bitartrate,                 One Stamford Forum,
                    acetaminophen, and          Stamford, CT 06901-3431
                    caffeine) Capsules
------------------------------------------------------------------------
ANDA 88-760        Mexate-AQ (methotrexate     Bristol-Myers Squibb Co.
                    sodium injection USP), 25
                    mg
------------------------------------------------------------------------
ANDA 88-780        Aristocort A Ointment       Astellas Pharma US, Inc.
                    (triamcinolone acetonide
                    ointment USP), 0.1%
------------------------------------------------------------------------
ANDA 88-781        Aristocort A                Do.
                    (triamcinolone acetonide)
                    Ointment, 0.5%
------------------------------------------------------------------------
ANDA 88-944        Sedapap (butalbital and     Merz Pharmaceuticals,
                    acetaminophen) Tablets,     LLC, 4215 Tudor Lane,
                    50 mg/650 mg                Greensboro, NC 27410
------------------------------------------------------------------------
ANDA 89-887        Mexate-AQ Preserved         Bristol-Myers Squibb Co.
                    (methotrexate sodium
                    injection USP), 25 mg/mL
------------------------------------------------------------------------

    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, 
approval of the applications listed in the table in this document, and 
all amendments and

[[Page 62863]]

supplements thereto, is hereby withdrawn, effective December 7, 2007.

    Dated: October 26, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E7-21886 Filed 11-6-07; 8:45 am]
BILLING CODE 4160-01-S