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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2009-N-0211]
 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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.
                    ( print page 23408) Application No.
Drug
ApplicantNDA 6-403
Priscoline (tolazoline hydrochloride (HCl)
Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936-1080NDA 8-303
Apresoline (hydralazine HCl)
Do.NDA 9-087
Hydergine (ergoloid mesylates) Sublingual Tablets
Do.NDA 9-509
Aramine (metaraminol bitartrate) Injection, 10 milligrams (mg)/milliliter (mL)
Merck & Co., Inc., UG2C-50, P.O. Box 1000, North Wales, PA 19454-1099NDA 9-987
Delta-Cortef (prednisolone) Tablets
Pharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42d St., New York, NY 10017NDA 10-060
Florinef (fludrocortisone acetate) Tablets
King Pharmaceuticals, Inc., 501 5th St., Bristol, TN 37620NDA 10-392
Atarax (hydroxyzine HCl) Tablets
Pfizer, Inc., 235 East 42d St., New York, NY 10017NDA 10-485
Atarax (hydroxyzine HCl) Syrup
Roerig Pharmaceuticals, c/o Pfizer, Inc.NDA 10-571
Compazine (prochlorperazine maleate) Tablets
GlaxoSmithKline, 1250 South Collegeville Rd., UP4110, Collegeville, PA 19426NDA 10-611
Halotestin (fluoxymesterone) Tablets, 2 mg, 5 mg, and 10 mg
Pharmacia & Upjohn Co., c/o Pfizer, Inc.NDA 10-686
Moderil (rescinnamine) Tablets, 0.25 mg and 0.5 mg
Pfizer, Inc.NDA 10-742
Compazine (prochlorperazine edisylate) Injection
GlaxoSmithKlineNDA 10-976
Enovid/Enovid-E/Enovid-E 21 (norethynodrel and mestranol) Tablets
G.D. Searle LLC, c/o Pfizer, Inc.NDA 11-000
Compazine (prochlorperazine maleate) Extended-Release Capsules
GlaxoSmithKlineNDA 11-111
Vistaril (hydroyzine HCl) Injection
Pfizer, Inc.NDA 11-127
Compazine (prochlorperazine) Suppositories
GlaxoSmithKlineNDA 11-188
Compazine (prochlorperazine edisylate) Syrup
Do.NDA 11-556
Anturane (sulfinpyrazone) Tablets and Capsules
Novartis Pharmaceuticals Corp.NDA 11-635
Diupres (chlorothiazide and reserpine) Tablets
Merck & Co., Inc.NDA 11-793
Esidrix (hydrochlorothiazide) Tablets
Novartis Pharmaceuticals Corp.NDA 11-838
Tofranil (imipramine HCl) Injection
Do.NDA 12-193
Ser-Ap-Es (reserpine, hydralazine HCl, and hydrochlorothiazide) Tablets
Do.NDA 12-329
Ismelin (guanethidine monosulfate) Tablets
Do.NDA 12-753
Torecan (thiethylperazine maleate) Tablets, 10 mg
Do.NDA 12-754
Torecan (thiethylperazine maleate) Injection, 5 mg/mL
Do.NDA 12-791
Hypertensin (angiotensin amide) Injection
Do.NDA 12-845
Renese (polythiazide) Tablets, 1 mg, 2 mg, and 4 mg
Pfizer, Inc.NDA 13-636
Renese-R (polythiazide and reserpine) Tablets, 2 mg/0.25 mg
Do.NDA 15-500
Tolinase (tolazamide) Tablets
Pharmacia & Upjohn Co., c/o Pfizer, Inc.NDA 16-029
Ovulen (ethynodiol diacetate and mestranol) Tablets
G.D. Searle LLC, c/o Pfizer, Inc.NDA 16-126
Primatene (epinephrine bitartrate) Mist, 0.2 mg, and Bronitin (epinephrine bitartrate) Mist, 0.3 mg
Wyeth Consumer Healthcare, Five Giralda Farms, Madison, NJ 07940NDA 16-635
Cyanocobalamin CO-57 Schilling Test Kit
Mallinckrodt Medical, c/o Mallinckrodt, Inc., 675 McDonnell Blvd., Hazelwood, MO 63042( print page 23409)NDA 16-705
Ovulen-28 (ethynodiol diacetate and mestranol) Tablets
G.D. Searle LLC, c/o Pfizer, Inc.NDA 16-709
Ortho-Novum 1/50-28 (norethindrone and mestranol) Tablets
Ortho-McNeil-Janssen Pharmaceutical, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLC, 920 Rt. 202, P.O. Box 300, Raritan, NJ 08869NDA 16-758
Navane (thiothixene HCl) Oral Concentrate
Pfizer, Inc.NDA 16-834
Lithane (lithium carbonate) Tablets
Do.NDA 16-904
Navane (thiothixene HCl) Injection
Do.NDA 17-059
TechneColl (technetium Tc-99m sulfur colloid kit)
Mallinckrodt Medical, c/o Mallinckrodt, Inc.NDA 17-247
Sanorex (mazindol) Tablets
Novartis Pharmaceuticals Corp.NDA 17-476
Slow-K (potassium chloride) Extended-Release Tablets
Do.NDA 17-543
Ludiomil (maprotiline HCl) Tablets, 25 mg, 50 mg, and 75 mg
Novartis Pharmaceuticals Corp.NDA 17-551
Perchloracap (potassium perchlorate) Capsules
Mallinckrodt Medical, c/o Mallinckrodt, Inc.NDA 17-842
TechneScan MAA (technetium Tc-99m albumin aggregate kit)
Do.NDA 17-844
Radioiodinated Serum Albumin (Human) IHSA I-125 (iodinated I-125 albumin injection)
Do.NDA 17-851
Lioresal (baclofen) Tablets, 10 mg and 20 mg
Novartis Pharmaceuticals Corp.NDA 17-971
Eskalith (lithium carbonate) Tablets, 300 mg
JDS Pharmaceuticals, LLC, c/o Noven Pharmaceuticals, Inc., 11960 SW. 44th St., Miami, FL 33186NDA 17-986
Minizide (prazosin HCl and polythiazide) Capsules, 1 mg, 2 mg, and 5 mg
Pfizer, Inc.NDA 18-006
Meclomen (meclofenamate sodium) Capsules, 50 mg and 100 mg
Parke-Davis, a subsidiary of Pfizer, Inc.NDA 18-152
Eskalith CR (lithium carbonate) Controlled-Release Tablets, 450 mg
JDS Pharmaceuticals, LLC, c/o Noven Pharmaceuticals, Inc.NDA 18-202
Cytadren (aminoglutethimide) Tablets
Novartis Pharmaceuticals Corp.NDA 18-245
Syntocinon (oxytocin) Injection
Do.NDA 18-249
Sodium Lactate Injection USP
Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045-5046NDA 18-272
Technescan Gluceptate (technetium Tc-99m gluceptate kit)
Draximage, a division of DRAXIS Specialty Pharmaceuticals, Inc., 16751 Autoroute TransCanada Highway, Kirkland, Qu. Canada H9H 4J4NDA 18-285
Visken (prindolol) Tablets
Novartis Pharmaceuticals Corp.NDA 18-535
Diulo (metolazone) Tablets, 2.5 mg, 5 mg, and 10 mg
G.D. Searle LLC, c/o Pfizer, Inc.NDA 18-536
Xenon Xe-127 Gas
Mallinckrodt, Inc.NDA 18-904
Urologic G (citric acid, sodium carbonate, and magnesium oxide) Irrigation in Plastic Containers
Hospira, Inc.NDA 19-650
Flumadine (rimantadine HCl) Syrup
Forest Laboratories, Inc., Harborside Financial Center III, suite 602, Jersey City, NJ 07311NDA 19-672
Efidac 24 Pseudoephedrine/Brompheniramine (pseudoephedrine HCl and brompheniramine maleate) Extended-Release Tablets
Alza Corp., 1900 Charleston Rd., P.O. Box 7210, Mountain View, CA 94039-7210NDA 19-721
Norditropin (somatropin recombinant) for Injection
Novo Nordisk Inc., 100 College Rd. West, Princeton, NJ 08540NDA 19-746
Efidac 24 Chlorpheniramine (chlorpheniramine maleate) Extended-Release Tablets
Alza Corp.( print page 23410)NDA 19-753
Ethmozine (moricizine HCl) Tablets
Shire Development, Inc., 725 Chesterbrook Blvd., Wayne, PA 19087NDA 19-762
Testoderm (testosterone) and Testoderm with Adhesive
Alza Corp.NDA 19-775
Minipress XL (prazosin HCl) Extended-Release Tablets
Pfizer, Inc.NDA 19-794
Depakote CP (divalproex sodium) Delayed-Release Tablets
Abbott Laboratories, 200 Abbott Park Rd., Abbott Park, IL 60664-6157NDA 19-863
Geref Diagnostic (sermorelin acetate) for Injection
EMD Serono, Inc., One Technology Dr., Rockland, MA 02370NDA 19-983
Prostep (nicotine) Transdermal System, 11 mg/24 hour (h) and 22 mg/24 h
Aveva Drug Delivery Systems, Inc., 3250 Commerce Pkwy., Miramar, FL 33025NDA 20-013
Maxaquin (lomefloxacin HCl) Tablets
Pharmacia & Upjohn Co., c/o Pfizer, Inc.NDA 20-044
Exosurf Neonatal (colfosceril palmitate, cetyl alcohol, and tyloxapol) Powder for Suspension
GlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709-3398NDA 20-087
Floxin (ofloxacin) Solution for Injection
Ortho-McNeil Pharmaceutical, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLCNDA 20-137
Demadex (torsemide) Injection
Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199NDA 20-144
Transderm-Nitro (nitroglycerin)
Novartis Pharmaceuticals Corp.NDA 20-154
Videx (didanosine) Chewable Tablets
Bristol-Meyers Squibb, 5 Research Pkwy., Signature 91 Bldg., Wallingford, CA 06492NDA 20-155
Videx (didanosine) Buffered Powder for Oral Solution
Do.NDA 20-199
Hivid (zalcitabine) Tablets
Hoffman-La Roche, Inc.NDA 20-250
Halfan (halofantrine HCl) Tablets
GlaxoSmithKline, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929NDA 20-306
Fludeoxyglucose F-18 Injection
Downstate Clinical PET Center—Methodist Medical Center of Illinois, 221 NE. Glen Oak Ave., Peoria, IL 61636-0002NDA 20-443
Geref (sermorelin acetate) for Injection
EMD Serono, Inc.NDA 20-545
Procanbid (procainamide HCl) Extended-Release Tablets, 500 mg and 1,000 mg
King Pharmaceuticals, Inc.NDA 20-686
LumenHance (manganese chloride tetrahydrate) for Solution
Bracco Diagnostics Inc., 107 College Rd. East, Princeton, NJ 08540NDA 20-773
SonoRX (simethicone coated cellulose) Suspension
Do.NDA 20-791
Testoderm TTS (testosterone transdermal system), 5 mg/24 h
Alza Corp.NDA 21-019
Compazine (prochlorperazine maleate) Extended-Release Capsules
GlaxoSmithKline, Collegeville, PA 19426NDA 21-868
Exubera (insulin recombinant human) Inhalation Powder, 1 mg and 3 mg
Pfizer, Inc.ANDA 40-092
Digoxin Injection USP, 0.1 mg/mL
Hospira, Inc.NDA 50-109
Mithracin (plicamycin) Injection, 2.5 mg
Pfizer, Inc.NDA 50-286
Terramycin (oxytetracycline HCl) Capsules
Do.NDA 50-316
Lincocin (lincomycin HCl) Capsules, 250 mg and 500 mg
Pharmacia & Upjohn Co., c/o Pfizer, Inc.NDA 50-461
Ancef (cefazolin) for Injection
SmithKline Beecham, d/b/a GlaxoSmithKline, Philadelphia, PA 19101-7929NDA 50-529
Pediazole (erythromycin ethylsuccinate and sulfisoxazole acetyl) for Oral Suspension
Ross Products Division, Abbott Laboratories, 3300 Stelzer Rd., Columbus, OH 43219-3034( print page 23411)NDA 50-613
Cefobid (cefoperazone sodium) Injection
Pfizer, Inc.NDA 50-667
Lorabid (loracarbef for oral suspension USP), 100 mg/5 mL and 200 mg/5 mL
King Pharmaceuticals, Inc.NDA 50-763
Mitozytrex (mitomycin) for Injection, 5 mg/vial
SuperGen, Inc., 4140 Dublin Blvd., suite 200, Dublin, CA 94568ANDA 61-014
Terramycin (oxytetracycline HCl) Ophthalmic Solution
Pfizer, Inc.ANDA 61-229
Polysporin Ophthalmic Ointment (bacitracin zinc and polymyxin B sulfate ophthalmic ointment)
Monarch Pharmaceuticals, Inc. (a wholly-owned subsidiary of King Pharmaceuticals, Inc.), 501 5th St., Bristol, TN 37620ANDA 64-099
Amikacin Sulfate Injection USP, 250 mg/mL
Hospira, Inc.ANDA 70-252
Naloxone HCl Injection USP, 0.02 mg/mL
Do.ANDA 70-253
Naloxone HCl Injection USP, 0.02 mg/mL
Do.ANDA 71-166
Bupivacaine HCl and Epinephrine Injection USP
Do.ANDA 71-169
Bupivacaine HCl and Epinephrine Injection USP
Do.ANDA 71-171
Bupivacaine HCl and Epinephrine Injection USP
Do.ANDA 73-685
Acilac (lactulose solution USP), 10 grams (g)/15 mL
Nostrum Laboratories, Inc., 1800 North Topping Ave., Kansas City, MO 64120ANDA 73-686
Laxilose (lactulose solution USP), 10 g/15 mL
Do.ANDA 74-083
Nitroglycerin in 5% Dextrose Injection, 0.1 mg/mL
Hospira, Inc.ANDA 74-127
Atenolol Tablets USP, 50 mg and 100 mg
Nostrum Laboratories, Inc.ANDA 74-337
Furosemide Injection USP, 10 mg/mL
Hospira, Inc.ANDA 74-391
Diclofenac Sodium Delayed-Release Tablets USP, 25 mg, 50 mg, and 75 mg
Roxane Laboratories, Inc., 1809 Wilson Rd., P.O. Box 16532, Columbus, OH 43216-6532ANDA 74-403
Dopamine HCl Injection USP, 40 mg/mL
Hospira, Inc.ANDA 74-404
Atenolol and Chlorthalidone Tablets USP, 50 mg/25 mg and 100 mg/25 mg
Nostrum Laboratories, Inc.ANDA 74-474
Pindolol Tablets USP, 5 mg and 10 mg
Do.ANDA 74-740
Atracurium Besylate Injection USP, 10 mg/mL
Hospira, Inc.ANDA 74-741
Atracurium Besylate Injection USP, 10 mg/mL
Do.ANDA 75-088
Cromoptic (cromolyn sodium) Ophthalmic Solution, 4%
King Pharmaceuticals, Inc.ANDA 75-162
Clozapine Tablets USP, 25 mg and 100 mg
Par Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977ANDA 75-466
Doxazosin Mesylate Tablets, 1 mg, 2 mg, 4 mg, and 8 mg
Genpharm Inc., c/o Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504-4310ANDA 75-558
Vecuronium Bromide for Injection, 4 mg/Ampul
Hospira, Inc.ANDA 75-762
Ofloxacin Injection, 40 mg/mL
Bedford Laboratories, Division of Ben Venue Laboratories, Inc., 300 Northfield Rd., Bedford, OH 44146ANDA 75-899
Fluvoxamine Maleate Tablets, 25 mg, 50 mg, and 100 mg
Synthon Pharmaceuticals, Inc., 9000 Development Dr., P.O. Box 110487, Research Triangle Park, NC 27709ANDA 76-138
Ciprofloxacin HCl Tablets USP, 250 mg, 500 mg, and 750 mg
Nostrum Laboratories, Inc.ANDA 76-213
Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg
Roxane Laboratories, Inc.ANDA 76-270
Mirtazapine Tablets USP, 15 mg, 30 mg, and 45 mg
Do.( print page 23412)ANDA 76-476
Benazepril HCl Tablets, 5 mg, 10 mg, 20 mg, and 40 mg
Mylan Pharmaceuticals, Inc.ANDA 76-489
Anagrelide HCl Capsules, 0.5 mg and 1 mg
Roxane Laboratories, Inc.ANDA 77-249
Oxandrolone Tablets USP, 2.5 mg and 10 mg
Do.ANDA 77-445
Polyethylene Glycol 3350 Powder for Oral Solution
Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454ANDA 77-648
Zonisamide Capsules, 25 mg, 50 mg, and 100 mg
Roxane Laboratories, Inc.ANDA 78-026
Paroxetine Tablets USP, 10 mg, 20 mg, 30 mg, and 40 mg
Do.ANDA 81-008
Strifon Forte DSC (chlorzoxazone tablets USP), 500 mg
Ferndale Laboratories, 780 West 8th Mile Rd., Ferndale, MI 48220ANDA 81-095
Acetaminophen, Aspirin, and Codeine Phosphate Capsules, 150 mg/180 mg/15 mg
Mikart, Inc., 1750 Chattahoochee Ave., Atlanta, GA 30318ANDA 83-283
Isoproterenol HCl Injection USP, 0.02 mg/mL
Hospira, Inc.ANDA 83-838
Promethazine HCl Injection USP
Do.ANDA 84-074
Bethanechol Chloride Tablets USP, 25 mg
Lannett Co., Inc., 9000 State Rd., Philadelphia, PA 19136ANDA 84-702
Bethanechol Chloride Tablets USP, 5 mg
Do.ANDA 84-712
Bethanechol Chloride Tablets USP, 10 mg
Do.ANDA 84-735
Apresazide (hydralazine HCl and hydrochlorothiazide) Capsules, 25 mg/25 mg
Novartis Pharmaceuticals Corp.ANDA 84-810
Apresazide (hydralazine HCl and hydrochlorothiazide) Capsules, 50 mg/50 mg
Do.ANDA 86-366
Acetaminophen and Codeine Phosphate Oral Solution USP, 120 mg/12 mg per 5 mL
Roxane Laboratories, Inc.ANDA 87-563
Quibron-T/SR (theophylline) Extended-Release Tablets, 300 mg
Monarch Pharmaceuticals, Inc.ANDA 88-126
Aminophylline Oral Solution USP, 105 mg/5 mL
Roxane Laboratories, Inc.ANDA 88-656
Quibron-T (theophylline) Tablets, 300 mg
Monarch Pharmaceuticals, Inc.ANDA 89-650
Lidocaine HCl and Epinephrine Injection USP
Hospira, Inc.
 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