Document ID: FDA-2009-N-0211-0001
Agency: fda
Document Type: Notice
Title: Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications
Posted Date: 2009-05-19T04:00Z

[Federal Register: May 19, 2009 (Volume 74, Number 95)]
[Notices]               
[Page 23407-23412]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my09-56]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0211]

 
Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 
92 New Drug Applications and 49 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 92 new drug applications (NDAs) and 49 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be withdrawn.

Dates: Effective: June 18, 2009.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

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.

[[Page 23408]]

------------------------------------------------------------------------
 Application No.             Drug                      Applicant
------------------------------------------------------------------------
NDA 6-403         Priscoline (tolazoline      Novartis Pharmaceuticals
                   hydrochloride (HCl)         Corp., One Health Plaza,
                                               East Hanover, NJ 07936-
                                               1080
------------------------------------------------------------------------
NDA 8-303         Apresoline (hydralazine     Do.
                   HCl)
------------------------------------------------------------------------
NDA 9-087         Hydergine (ergoloid         Do.
                   mesylates) Sublingual
                   Tablets
------------------------------------------------------------------------
NDA 9-509         Aramine (metaraminol        Merck & Co., Inc., UG2C-
                   bitartrate) Injection, 10   50, P.O. Box 1000, North
                   milligrams (mg)/            Wales, PA 19454-1099
                   milliliter (mL)
------------------------------------------------------------------------
NDA 9-987         Delta-Cortef                Pharmacia & Upjohn Co., c/
                   (prednisolone) Tablets      o Pfizer, Inc., 235 East
                                               42d St., New York, NY
                                               10017
------------------------------------------------------------------------
NDA 10-060        Florinef (fludrocortisone   King Pharmaceuticals,
                   acetate) Tablets            Inc., 501 5th St.,
                                               Bristol, TN 37620
------------------------------------------------------------------------
NDA 10-392        Atarax (hydroxyzine HCl)    Pfizer, Inc., 235 East 42d
                   Tablets                     St., New York, NY 10017
------------------------------------------------------------------------
NDA 10-485        Atarax (hydroxyzine HCl)    Roerig Pharmaceuticals, c/
                   Syrup                       o Pfizer, Inc.
------------------------------------------------------------------------
NDA 10-571        Compazine                   GlaxoSmithKline, 1250
                   (prochlorperazine           South Collegeville Rd.,
                   maleate) Tablets            UP4110, Collegeville, PA
                                               19426
------------------------------------------------------------------------
NDA 10-611        Halotestin                  Pharmacia & Upjohn Co., c/
                   (fluoxymesterone)           o Pfizer, Inc.
                   Tablets, 2 mg, 5 mg, and
                   10 mg
------------------------------------------------------------------------
NDA 10-686        Moderil (rescinnamine)      Pfizer, Inc.
                   Tablets, 0.25 mg and 0.5
                   mg
------------------------------------------------------------------------
NDA 10-742        Compazine                   GlaxoSmithKline
                   (prochlorperazine
                   edisylate) Injection
------------------------------------------------------------------------
NDA 10-976        Enovid/Enovid-E/Enovid-E    G.D. Searle LLC, c/o
                   21 (norethynodrel and       Pfizer, Inc.
                   mestranol) Tablets
------------------------------------------------------------------------
NDA 11-000        Compazine                   GlaxoSmithKline
                   (prochlorperazine
                   maleate) Extended-Release
                   Capsules
------------------------------------------------------------------------
NDA 11-111        Vistaril (hydroyzine HCl)   Pfizer, Inc.
                   Injection
------------------------------------------------------------------------
NDA 11-127        Compazine                   GlaxoSmithKline
                   (prochlorperazine)
                   Suppositories
------------------------------------------------------------------------
NDA 11-188        Compazine                   Do.
                   (prochlorperazine
                   edisylate) Syrup
------------------------------------------------------------------------
NDA 11-556        Anturane (sulfinpyrazone)   Novartis Pharmaceuticals
                   Tablets and Capsules        Corp.
------------------------------------------------------------------------
NDA 11-635        Diupres (chlorothiazide     Merck & Co., Inc.
                   and reserpine) Tablets
------------------------------------------------------------------------
NDA 11-793        Esidrix                     Novartis Pharmaceuticals
                   (hydrochlorothiazide)       Corp.
                   Tablets
------------------------------------------------------------------------
NDA 11-838        Tofranil (imipramine HCl)   Do.
                   Injection
------------------------------------------------------------------------
NDA 12-193        Ser-Ap-Es (reserpine,       Do.
                   hydralazine HCl, and
                   hydrochlorothiazide)
                   Tablets
------------------------------------------------------------------------
NDA 12-329        Ismelin (guanethidine       Do.
                   monosulfate) Tablets
------------------------------------------------------------------------
NDA 12-753        Torecan (thiethylperazine   Do.
                   maleate) Tablets, 10 mg
------------------------------------------------------------------------
NDA 12-754        Torecan (thiethylperazine   Do.
                   maleate) Injection, 5 mg/
                   mL
------------------------------------------------------------------------
NDA 12-791        Hypertensin (angiotensin    Do.
                   amide) Injection
------------------------------------------------------------------------
NDA 12-845        Renese (polythiazide)       Pfizer, Inc.
                   Tablets, 1 mg, 2 mg, and
                   4 mg
------------------------------------------------------------------------
NDA 13-636        Renese-R (polythiazide and  Do.
                   reserpine) Tablets, 2 mg/
                   0.25 mg
------------------------------------------------------------------------
NDA 15-500        Tolinase (tolazamide)       Pharmacia & Upjohn Co., c/
                   Tablets                     o Pfizer, Inc.
------------------------------------------------------------------------
NDA 16-029        Ovulen (ethynodiol          G.D. Searle LLC, c/o
                   diacetate and mestranol)    Pfizer, Inc.
                   Tablets
------------------------------------------------------------------------
NDA 16-126        Primatene (epinephrine      Wyeth Consumer Healthcare,
                   bitartrate) Mist, 0.2 mg,   Five Giralda Farms,
                   and Bronitin (epinephrine   Madison, NJ 07940
                   bitartrate) Mist, 0.3 mg
------------------------------------------------------------------------
NDA 16-635        Cyanocobalamin CO-57        Mallinckrodt Medical, c/o
                   Schilling Test Kit          Mallinckrodt, Inc., 675
                                               McDonnell Blvd.,
                                               Hazelwood, MO 63042
------------------------------------------------------------------------

[[Page 23409]]

NDA 16-705        Ovulen-28 (ethynodiol       G.D. Searle LLC, c/o
                   diacetate and mestranol)    Pfizer, Inc.
                   Tablets
------------------------------------------------------------------------
NDA 16-709        Ortho-Novum 1/50-28         Ortho-McNeil-Janssen
                   (norethindrone and          Pharmaceutical, Inc., c/o
                   mestranol) Tablets          Johnson & Johnson
                                               Pharmaceutical Research &
                                               Development, LLC, 920 Rt.
                                               202, P.O. Box 300,
                                               Raritan, NJ 08869
------------------------------------------------------------------------
NDA 16-758        Navane (thiothixene HCl)    Pfizer, Inc.
                   Oral Concentrate
------------------------------------------------------------------------
NDA 16-834        Lithane (lithium            Do.
                   carbonate) Tablets
------------------------------------------------------------------------
NDA 16-904        Navane (thiothixene HCl)    Do.
                   Injection
------------------------------------------------------------------------
NDA 17-059        TechneColl (technetium Tc-  Mallinckrodt Medical, c/o
                   99m sulfur colloid kit)     Mallinckrodt, Inc.
------------------------------------------------------------------------
NDA 17-247        Sanorex (mazindol) Tablets  Novartis Pharmaceuticals
                                               Corp.
------------------------------------------------------------------------
NDA 17-476        Slow-K (potassium           Do.
                   chloride) Extended-
                   Release Tablets
------------------------------------------------------------------------
NDA 17-543        Ludiomil (maprotiline HCl)  Novartis Pharmaceuticals
                   Tablets, 25 mg, 50 mg,      Corp.
                   and 75 mg
------------------------------------------------------------------------
NDA 17-551        Perchloracap (potassium     Mallinckrodt Medical, c/o
                   perchlorate) Capsules       Mallinckrodt, Inc.
------------------------------------------------------------------------
NDA 17-842        TechneScan MAA (technetium  Do.
                   Tc-99m albumin aggregate
                   kit)
------------------------------------------------------------------------
NDA 17-844        Radioiodinated Serum        Do.
                   Albumin (Human) IHSA I-
                   125 (iodinated I-125
                   albumin injection)
------------------------------------------------------------------------
NDA 17-851        Lioresal (baclofen)         Novartis Pharmaceuticals
                   Tablets, 10 mg and 20 mg    Corp.
------------------------------------------------------------------------
NDA 17-971        Eskalith (lithium           JDS Pharmaceuticals, LLC,
                   carbonate) Tablets, 300     c/o Noven
                   mg                          Pharmaceuticals, Inc.,
                                               11960 SW. 44th St.,
                                               Miami, FL 33186
------------------------------------------------------------------------
NDA 17-986        Minizide (prazosin HCl and  Pfizer, Inc.
                   polythiazide) Capsules, 1
                   mg, 2 mg, and 5 mg
------------------------------------------------------------------------
NDA 18-006        Meclomen (meclofenamate     Parke-Davis, a subsidiary
                   sodium) Capsules, 50 mg     of Pfizer, Inc.
                   and 100 mg
------------------------------------------------------------------------
NDA 18-152        Eskalith CR (lithium        JDS Pharmaceuticals, LLC,
                   carbonate) Controlled-      c/o Noven
                   Release Tablets, 450 mg     Pharmaceuticals, Inc.
------------------------------------------------------------------------
NDA 18-202        Cytadren                    Novartis Pharmaceuticals
                   (aminoglutethimide)         Corp.
                   Tablets
------------------------------------------------------------------------
NDA 18-245        Syntocinon (oxytocin)       Do.
                   Injection
------------------------------------------------------------------------
NDA 18-249        Sodium Lactate Injection    Hospira, Inc., 275 North
                   USP                         Field Dr., Lake Forest,
                                               IL 60045-5046
------------------------------------------------------------------------
NDA 18-272        Technescan Gluceptate       Draximage, a division of
                   (technetium Tc-99m          DRAXIS Specialty
                   gluceptate kit)             Pharmaceuticals, Inc.,
                                               16751 Autoroute
                                               TransCanada Highway,
                                               Kirkland, Qu. Canada H9H
                                               4J4
------------------------------------------------------------------------
NDA 18-285        Visken (prindolol) Tablets  Novartis Pharmaceuticals
                                               Corp.
------------------------------------------------------------------------
NDA 18-535        Diulo (metolazone)          G.D. Searle LLC, c/o
                   Tablets, 2.5 mg, 5 mg,      Pfizer, Inc.
                   and 10 mg
------------------------------------------------------------------------
NDA 18-536        Xenon Xe-127 Gas            Mallinckrodt, Inc.
------------------------------------------------------------------------
NDA 18-904        Urologic G (citric acid,    Hospira, Inc.
                   sodium carbonate, and
                   magnesium oxide)
                   Irrigation in Plastic
                   Containers
------------------------------------------------------------------------
NDA 19-650        Flumadine (rimantadine      Forest Laboratories, Inc.,
                   HCl) Syrup                  Harborside Financial
                                               Center III, suite 602,
                                               Jersey City, NJ 07311
------------------------------------------------------------------------
NDA 19-672        Efidac 24 Pseudoephedrine/  Alza Corp., 1900
                   Brompheniramine             Charleston Rd., P.O. Box
                   (pseudoephedrine HCl and    7210, Mountain View, CA
                   brompheniramine maleate)    94039-7210
                   Extended-Release Tablets
------------------------------------------------------------------------
NDA 19-721        Norditropin (somatropin     Novo Nordisk Inc., 100
                   recombinant) for            College Rd. West,
                   Injection                   Princeton, NJ 08540
------------------------------------------------------------------------
NDA 19-746        Efidac 24 Chlorpheniramine  Alza Corp.
                   (chlorpheniramine
                   maleate) Extended-Release
                   Tablets
------------------------------------------------------------------------

[[Page 23410]]

NDA 19-753        Ethmozine (moricizine HCl)  Shire Development, Inc.,
                   Tablets                     725 Chesterbrook Blvd.,
                                               Wayne, PA 19087
------------------------------------------------------------------------
NDA 19-762        Testoderm (testosterone)    Alza Corp.
                   and Testoderm with
                   Adhesive
------------------------------------------------------------------------
NDA 19-775        Minipress XL (prazosin      Pfizer, Inc.
                   HCl) Extended-Release
                   Tablets
------------------------------------------------------------------------
NDA 19-794        Depakote CP (divalproex     Abbott Laboratories, 200
                   sodium) Delayed-Release     Abbott Park Rd., Abbott
                   Tablets                     Park, IL 60664-6157
------------------------------------------------------------------------
NDA 19-863        Geref Diagnostic            EMD Serono, Inc., One
                   (sermorelin acetate) for    Technology Dr., Rockland,
                   Injection                   MA 02370
------------------------------------------------------------------------
NDA 19-983        Prostep (nicotine)          Aveva Drug Delivery
                   Transdermal System, 11 mg/  Systems, Inc., 3250
                   24 hour (h) and 22 mg/24    Commerce Pkwy., Miramar,
                   h                           FL 33025
------------------------------------------------------------------------
NDA 20-013        Maxaquin (lomefloxacin      Pharmacia & Upjohn Co., c/
                   HCl) Tablets                o Pfizer, Inc.
------------------------------------------------------------------------
NDA 20-044        Exosurf Neonatal            GlaxoSmithKline, P.O. Box
                   (colfosceril palmitate,     13398, Five Moore Dr.,
                   cetyl alcohol, and          Research Triangle Park,
                   tyloxapol) Powder for       NC 27709-3398
                   Suspension
------------------------------------------------------------------------
NDA 20-087        Floxin (ofloxacin)          Ortho-McNeil
                   Solution for Injection      Pharmaceutical, Inc., c/o
                                               Johnson & Johnson
                                               Pharmaceutical Research &
                                               Development, LLC
------------------------------------------------------------------------
NDA 20-137        Demadex (torsemide)         Hoffman-La Roche, Inc.,
                   Injection                   340 Kingsland St.,
                                               Nutley, NJ 07110-1199
------------------------------------------------------------------------
NDA 20-144        Transderm-Nitro             Novartis Pharmaceuticals
                   (nitroglycerin)             Corp.
------------------------------------------------------------------------
NDA 20-154        Videx (didanosine)          Bristol-Meyers Squibb, 5
                   Chewable Tablets            Research Pkwy., Signature
                                               91 Bldg., Wallingford, CA
                                               06492
------------------------------------------------------------------------
NDA 20-155        Videx (didanosine)          Do.
                   Buffered Powder for Oral
                   Solution
------------------------------------------------------------------------
NDA 20-199        Hivid (zalcitabine)         Hoffman-La Roche, Inc.
                   Tablets
------------------------------------------------------------------------
NDA 20-250        Halfan (halofantrine HCl)   GlaxoSmithKline, One
                   Tablets                     Franklin Plaza, P.O. Box
                                               7929, Philadelphia, PA
                                               19101-7929
------------------------------------------------------------------------
NDA 20-306        Fludeoxyglucose F-18        Downstate Clinical PET
                   Injection                   Center--Methodist Medical
                                               Center of Illinois, 221
                                               NE. Glen Oak Ave.,
                                               Peoria, IL 61636-0002
------------------------------------------------------------------------
NDA 20-443        Geref (sermorelin acetate)  EMD Serono, Inc.
                   for Injection
------------------------------------------------------------------------
NDA 20-545        Procanbid (procainamide     King Pharmaceuticals, Inc.
                   HCl) Extended-Release
                   Tablets, 500 mg and 1,000
                   mg
------------------------------------------------------------------------
NDA 20-686        LumenHance (manganese       Bracco Diagnostics Inc.,
                   chloride tetrahydrate)      107 College Rd. East,
                   for Solution                Princeton, NJ 08540
------------------------------------------------------------------------
NDA 20-773        SonoRX (simethicone coated  Do.
                   cellulose) Suspension
------------------------------------------------------------------------
NDA 20-791        Testoderm TTS               Alza Corp.
                   (testosterone transdermal
                   system), 5 mg/24 h
------------------------------------------------------------------------
NDA 21-019        Compazine                   GlaxoSmithKline,
                   (prochlorperazine           Collegeville, PA 19426
                   maleate) Extended-Release
                   Capsules
------------------------------------------------------------------------
NDA 21-868        Exubera (insulin            Pfizer, Inc.
                   recombinant human)
                   Inhalation Powder, 1 mg
                   and 3 mg
------------------------------------------------------------------------
ANDA 40-092       Digoxin Injection USP, 0.1  Hospira, Inc.
                   mg/mL
------------------------------------------------------------------------
NDA 50-109        Mithracin (plicamycin)      Pfizer, Inc.
                   Injection, 2.5 mg
------------------------------------------------------------------------
NDA 50-286        Terramycin                  Do.
                   (oxytetracycline HCl)
                   Capsules
------------------------------------------------------------------------
NDA 50-316        Lincocin (lincomycin HCl)   Pharmacia & Upjohn Co., c/
                   Capsules, 250 mg and 500    o Pfizer, Inc.
                   mg
------------------------------------------------------------------------
NDA 50-461        Ancef (cefazolin) for       SmithKline Beecham, d/b/a
                   Injection                   GlaxoSmithKline,
                                               Philadelphia, PA 19101-
                                               7929
------------------------------------------------------------------------
NDA 50-529        Pediazole (erythromycin     Ross Products Division,
                   ethylsuccinate and          Abbott Laboratories, 3300
                   sulfisoxazole acetyl) for   Stelzer Rd., Columbus, OH
                   Oral Suspension             43219-3034
------------------------------------------------------------------------

[[Page 23411]]

NDA 50-613        Cefobid (cefoperazone       Pfizer, Inc.
                   sodium) Injection
------------------------------------------------------------------------
NDA 50-667        Lorabid (loracarbef for     King Pharmaceuticals, Inc.
                   oral suspension USP), 100
                   mg/5 mL and 200 mg/5 mL
------------------------------------------------------------------------
NDA 50-763        Mitozytrex (mitomycin) for  SuperGen, Inc., 4140
                   Injection, 5 mg/vial        Dublin Blvd., suite 200,
                                               Dublin, CA 94568
------------------------------------------------------------------------
ANDA 61-014       Terramycin                  Pfizer, Inc.
                   (oxytetracycline HCl)
                   Ophthalmic Solution
------------------------------------------------------------------------
ANDA 61-229       Polysporin Ophthalmic       Monarch Pharmaceuticals,
                   Ointment (bacitracin zinc   Inc. (a wholly-owned
                   and polymyxin B sulfate     subsidiary of King
                   ophthalmic ointment)        Pharmaceuticals, Inc.),
                                               501 5th St., Bristol, TN
                                               37620
------------------------------------------------------------------------
ANDA 64-099       Amikacin Sulfate Injection  Hospira, Inc.
                   USP, 250 mg/mL
------------------------------------------------------------------------
ANDA 70-252       Naloxone HCl Injection      Do.
                   USP, 0.02 mg/mL
------------------------------------------------------------------------
ANDA 70-253       Naloxone HCl Injection      Do.
                   USP, 0.02 mg/mL
------------------------------------------------------------------------
ANDA 71-166       Bupivacaine HCl and         Do.
                   Epinephrine Injection USP
------------------------------------------------------------------------
ANDA 71-169       Bupivacaine HCl and         Do.
                   Epinephrine Injection USP
------------------------------------------------------------------------
ANDA 71-171       Bupivacaine HCl and         Do.
                   Epinephrine Injection USP
------------------------------------------------------------------------
ANDA 73-685       Acilac (lactulose solution  Nostrum Laboratories,
                   USP), 10 grams (g)/15 mL    Inc., 1800 North Topping
                                               Ave., Kansas City, MO
                                               64120
------------------------------------------------------------------------
ANDA 73-686       Laxilose (lactulose         Do.
                   solution USP), 10 g/15 mL
------------------------------------------------------------------------
ANDA 74-083       Nitroglycerin in 5%         Hospira, Inc.
                   Dextrose Injection, 0.1
                   mg/mL
------------------------------------------------------------------------
ANDA 74-127       Atenolol Tablets USP, 50    Nostrum Laboratories, Inc.
                   mg and 100 mg
------------------------------------------------------------------------
ANDA 74-337       Furosemide Injection USP,   Hospira, Inc.
                   10 mg/mL
------------------------------------------------------------------------
ANDA 74-391       Diclofenac Sodium Delayed-  Roxane Laboratories, Inc.,
                   Release Tablets USP, 25     1809 Wilson Rd., P.O. Box
                   mg, 50 mg, and 75 mg        16532, Columbus, OH 43216-
                                               6532
------------------------------------------------------------------------
ANDA 74-403       Dopamine HCl Injection      Hospira, Inc.
                   USP, 40 mg/mL
------------------------------------------------------------------------
ANDA 74-404       Atenolol and                Nostrum Laboratories, Inc.
                   Chlorthalidone Tablets
                   USP, 50 mg/25 mg and 100
                   mg/25 mg
------------------------------------------------------------------------
ANDA 74-474       Pindolol Tablets USP, 5 mg  Do.
                   and 10 mg
------------------------------------------------------------------------
ANDA 74-740       Atracurium Besylate         Hospira, Inc.
                   Injection USP, 10 mg/mL
------------------------------------------------------------------------
ANDA 74-741       Atracurium Besylate         Do.
                   Injection USP, 10 mg/mL
------------------------------------------------------------------------
ANDA 75-088       Cromoptic (cromolyn         King Pharmaceuticals, Inc.
                   sodium) Ophthalmic
                   Solution, 4%
------------------------------------------------------------------------
ANDA 75-162       Clozapine Tablets USP, 25   Par Pharmaceutical, Inc.,
                   mg and 100 mg               One Ram Ridge Rd., Spring
                                               Valley, NY 10977
------------------------------------------------------------------------
ANDA 75-466       Doxazosin Mesylate          Genpharm Inc., c/o Mylan
                   Tablets, 1 mg, 2 mg, 4      Pharmaceuticals, Inc.,
                   mg, and 8 mg                781 Chestnut Ridge Rd.,
                                               P.O. Box 4310,
                                               Morgantown, WV 26504-4310
------------------------------------------------------------------------
ANDA 75-558       Vecuronium Bromide for      Hospira, Inc.
                   Injection, 4 mg/Ampul
------------------------------------------------------------------------
ANDA 75-762       Ofloxacin Injection, 40 mg/ Bedford Laboratories,
                   mL                          Division of Ben Venue
                                               Laboratories, Inc., 300
                                               Northfield Rd., Bedford,
                                               OH 44146
------------------------------------------------------------------------
ANDA 75-899       Fluvoxamine Maleate         Synthon Pharmaceuticals,
                   Tablets, 25 mg, 50 mg,      Inc., 9000 Development
                   and 100 mg                  Dr., P.O. Box 110487,
                                               Research Triangle Park,
                                               NC 27709
------------------------------------------------------------------------
ANDA 76-138       Ciprofloxacin HCl Tablets   Nostrum Laboratories, Inc.
                   USP, 250 mg, 500 mg, and
                   750 mg
------------------------------------------------------------------------
ANDA 76-213       Fluconazole Tablets, 50     Roxane Laboratories, Inc.
                   mg, 100 mg, 150 mg, and
                   200 mg
------------------------------------------------------------------------
ANDA 76-270       Mirtazapine Tablets USP,    Do.
                   15 mg, 30 mg, and 45 mg
------------------------------------------------------------------------

[[Page 23412]]

ANDA 76-476       Benazepril HCl Tablets, 5   Mylan Pharmaceuticals,
                   mg, 10 mg, 20 mg, and 40    Inc.
                   mg
------------------------------------------------------------------------
ANDA 76-489       Anagrelide HCl Capsules,    Roxane Laboratories, Inc.
                   0.5 mg and 1 mg
------------------------------------------------------------------------
ANDA 77-249       Oxandrolone Tablets USP,    Do.
                   2.5 mg and 10 mg
------------------------------------------------------------------------
ANDA 77-445       Polyethylene Glycol 3350    Teva Pharmaceuticals USA,
                   Powder for Oral Solution    1090 Horsham Rd., P.O.
                                               Box 1090, North Wales, PA
                                               19454
------------------------------------------------------------------------
ANDA 77-648       Zonisamide Capsules, 25     Roxane Laboratories, Inc.
                   mg, 50 mg, and 100 mg
------------------------------------------------------------------------
ANDA 78-026       Paroxetine Tablets USP, 10  Do.
                   mg, 20 mg, 30 mg, and 40
                   mg
------------------------------------------------------------------------
ANDA 81-008       Strifon Forte DSC           Ferndale Laboratories, 780
                   (chlorzoxazone tablets      West 8th Mile Rd.,
                   USP), 500 mg                Ferndale, MI 48220
------------------------------------------------------------------------
ANDA 81-095       Acetaminophen, Aspirin,     Mikart, Inc., 1750
                   and Codeine Phosphate       Chattahoochee Ave.,
                   Capsules, 150 mg/180 mg/    Atlanta, GA 30318
                   15 mg
------------------------------------------------------------------------
ANDA 83-283       Isoproterenol HCl           Hospira, Inc.
                   Injection USP, 0.02 mg/mL
------------------------------------------------------------------------
ANDA 83-838       Promethazine HCl Injection  Do.
                   USP
------------------------------------------------------------------------
ANDA 84-074       Bethanechol Chloride        Lannett Co., Inc., 9000
                   Tablets USP, 25 mg          State Rd., Philadelphia,
                                               PA 19136
------------------------------------------------------------------------
ANDA 84-702       Bethanechol Chloride        Do.
                   Tablets USP, 5 mg
------------------------------------------------------------------------
ANDA 84-712       Bethanechol Chloride        Do.
                   Tablets USP, 10 mg
------------------------------------------------------------------------
ANDA 84-735       Apresazide (hydralazine     Novartis Pharmaceuticals
                   HCl and                     Corp.
                   hydrochlorothiazide)
                   Capsules, 25 mg/25 mg
------------------------------------------------------------------------
ANDA 84-810       Apresazide (hydralazine     Do.
                   HCl and
                   hydrochlorothiazide)
                   Capsules, 50 mg/50 mg
------------------------------------------------------------------------
ANDA 86-366       Acetaminophen and Codeine   Roxane Laboratories, Inc.
                   Phosphate Oral Solution
                   USP, 120 mg/12 mg per 5
                   mL
------------------------------------------------------------------------
ANDA 87-563       Quibron-T/SR                Monarch Pharmaceuticals,
                   (theophylline) Extended-    Inc.
                   Release Tablets, 300 mg
------------------------------------------------------------------------
ANDA 88-126       Aminophylline Oral          Roxane Laboratories, Inc.
                   Solution USP, 105 mg/5 mL
------------------------------------------------------------------------
ANDA 88-656       Quibron-T (theophylline)    Monarch Pharmaceuticals,
                   Tablets, 300 mg             Inc.
------------------------------------------------------------------------
ANDA 89-650       Lidocaine HCl and           Hospira, Inc.
                   Epinephrine Injection USP
------------------------------------------------------------------------

    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 June 18, 2009.

    Dated: April 30, 2009.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E9-11628 Filed 5-18-09; 8:45 am]

BILLING CODE 4160-01-S