Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications, 23407-23412 [E9-11628]

Download as PDF Federal Register / Vol. 74, No. 95 / Tuesday, May 19, 2009 / Notices SUPPLEMENTARY INFORMATION: A. Purpose The GSAR provision at 552.219–72 requires a contractor (except small business concerns) to submit a subcontracting plan when a negotiated acquisition including construction, repair, and alterations and lease contracts (except those solicitations using simplified procedures) meets all four of the following conditions. 1. When the contracting officer anticipates receiving individual subcontracting plans (not commercial plans). 2. When award is based on trade-offs among cost or price and technical and/ or management factors under FAR 15.101–1. 3. The acquisition is not a commercial item acquisition. 4. The acquisition offers more than minimal subcontracting opportunities. Project Period: 12 months with option for four additional years of funding at the same level. Justification for Exception to Competition: The American Hospital Association, has many years of experience conducting surveys with a high response rate across all United States hospitals. Name and Address of Awarding Office Official: Marc Weisman, Executive Director, Office of the National Coordinator for Health Information Technology, Department of Health and Human Services, 200 Independence Avenue, SW., Washington DC 20201. Dated: May 13, 2009. Marc Weisman, Executive Director, Office of the National Coordinator for Health Information Technology. [FR Doc. E9–11672 Filed 5–18–09; 8:45 am] Dated: May 12, 2009. Al Matera, Director, Office of Acquisition Policy. [FR Doc. E9–11588 Filed 5–18–09; 8:45 am] BILLING CODE 6820–61–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Coordinator for Health Information Technology mstockstill on PROD1PC66 with NOTICES Announcement of grant award. VerDate Nov<24>2008 17:02 May 18, 2009 Jkt 217001 Agenda: Topics to be discussed include updates from Council subcommittees on Reform of the Faithbased and Neighborhood Partnerships Office, Economic Recovery, Fatherhood and Healthy Families, Inter-religious Dialogue and Cooperation, Environment and Climate Change and Global Poverty and Development. Dated: May 13, 2009. Mara Vanderslice, Special Assistant. [FR Doc. E9–11610 Filed 5–18–09; 8:45 am] BILLING CODE 4154–07–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0211] Respondents: 1,020. Responses per Respondent: 1. Hours per Response: 12. Total Burden Hours: 12,240. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (VPR), 1800 F Street, NW., Room 4041, Washington, DC 20405, telephone (202) 501–4755. Please cite OMB Control No. 3090–0252, Preparation, Submission, and Negotiation of Subcontracting Plans, in all correspondence. Recipient: American Hospital Association. Purpose of Award: ONC announces the award of a grant to the American Hospital Association to fund a supplement to the Association’s national survey of hospitals that will measure the adoption and use of electronic health records by these providers. Amount of Award: $101,973. contact Mara Vanderslice for more information about how to join the call. BILLING CODE 4150–45–P B. Annual Reporting Burden ACTION: 23407 DEPARTMENT OF HEALTH AND HUMAN SERVICES President’s Advisory Council for Faithbased and Neighborhood Partnerships In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the President’s Advisory Council for Faith-based and Neighborhood Partnerships announces the following meetings: Name: President’s Advisory Council for Faith-based and Neighborhood Partnerships Council meetings Times and Dates: Thursday, June 4th at 2 p.m. Eastern; and Tuesday, June 16th at 4 p.m. Eastern. Place: Meetings will be held via conference call. Status: Open to the public, limited only by the space available. Purpose: The Council brings together leaders and experts in fields related to the work of faith-based and neighborhood organizations in order to: Identify best practices and successful modes of delivering social services; evaluate the need for improvements in the implementation and coordination of public policies relating to faith-based and other neighborhood organizations; and make recommendations for changes in policies, programs, and practices. Contact Person for Additional Information: Mara Vanderslice, 202– 205–2419, mara.vanderslice@hhs.gov. Supplementary Information: The meetings will be held via conference call. There is limited capacity to join the call and will be listen-only mode. Please PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 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. 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. SUPPLEMENTARY INFORMATION: E:\FR\FM\19MYN1.SGM 19MYN1 23408 Federal Register / Vol. 74, No. 95 / Tuesday, May 19, 2009 / Notices Application No. Drug Applicant Priscoline (tolazoline hydrochloride (HCl) Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936–1080 NDA 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 19454–1099 NDA 9–987 Delta-Cortef (prednisolone) Tablets Pharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42d St., New York, NY 10017 NDA 10–060 Florinef (fludrocortisone acetate) Tablets King Pharmaceuticals, Inc., 501 5th St., Bristol, TN 37620 NDA 10–392 Atarax (hydroxyzine HCl) Tablets Pfizer, Inc., 235 East 42d St., New York, NY 10017 NDA 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 19426 NDA 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 GlaxoSmithKline NDA 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 GlaxoSmithKline NDA 11–111 Vistaril (hydroyzine HCl) Injection Pfizer, Inc. NDA 11–127 Compazine (prochlorperazine) Suppositories GlaxoSmithKline NDA 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 mstockstill on PROD1PC66 with NOTICES NDA 6–403 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 07940 NDA 16–635 Cyanocobalamin CO–57 Schilling Test Kit Mallinckrodt Medical, c/o Mallinckrodt, Inc., 675 McDonnell Blvd., Hazelwood, MO 63042 VerDate Nov<24>2008 16:48 May 18, 2009 Jkt 217001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1 Federal Register / Vol. 74, No. 95 / Tuesday, May 19, 2009 / Notices Application No. Drug 23409 Applicant 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 08869 NDA 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 33186 NDA 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 60045–5046 NDA 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 4J4 NDA 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 07311 NDA 19–672 mstockstill on PROD1PC66 with NOTICES NDA 16–705 Efidac 24 Pseudoephedrine/Brompheniramine (pseudoephedrine HCl and brompheniramine maleate) Extended-Release Tablets Alza Corp., 1900 Charleston Rd., P.O. Box 7210, Mountain View, CA 94039–7210 NDA 19–721 Norditropin (somatropin recombinant) for Injection Novo Nordisk Inc., 100 College Rd. West, Princeton, NJ 08540 NDA 19–746 Efidac 24 Chlorpheniramine (chlorpheniramine maleate) Extended-Release Tablets Alza Corp. VerDate Nov<24>2008 16:48 May 18, 2009 Jkt 217001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1 23410 Federal Register / Vol. 74, No. 95 / Tuesday, May 19, 2009 / Notices Application No. Drug Applicant Ethmozine (moricizine HCl) Tablets Shire Development, Inc., 725 Chesterbrook Blvd., Wayne, PA 19087 NDA 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 60664–6157 NDA 19–863 Geref Diagnostic (sermorelin acetate) for Injection EMD Serono, Inc., One Technology Dr., Rockland, MA 02370 NDA 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 33025 NDA 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 27709–3398 NDA 20–087 Floxin (ofloxacin) Solution for Injection Ortho-McNeil Pharmaceutical, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLC NDA 20–137 Demadex (torsemide) Injection Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110–1199 NDA 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 06492 NDA 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 19101–7929 NDA 20–306 Fludeoxyglucose F–18 Injection Downstate Clinical PET Center—Methodist Medical Center of Illinois, 221 NE. Glen Oak Ave., Peoria, IL 61636–0002 NDA 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 08540 NDA 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 19426 NDA 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 mstockstill on PROD1PC66 with NOTICES NDA 19–753 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 19101–7929 NDA 50–529 Pediazole (erythromycin ethylsuccinate and sulfisoxazole acetyl) for Oral Suspension Ross Products Division, Abbott Laboratories, 3300 Stelzer Rd., Columbus, OH 43219–3034 VerDate Nov<24>2008 16:48 May 18, 2009 Jkt 217001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1 Federal Register / Vol. 74, No. 95 / Tuesday, May 19, 2009 / Notices Application No. Drug 23411 Applicant 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 94568 ANDA 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 37620 ANDA 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 64120 ANDA 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 43216–6532 ANDA 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 10977 ANDA 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 26504–4310 ANDA 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 44146 ANDA 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 27709 ANDA 76–138 mstockstill on PROD1PC66 with NOTICES NDA 50–613 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. VerDate Nov<24>2008 16:48 May 18, 2009 Jkt 217001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1 23412 Federal Register / Vol. 74, No. 95 / Tuesday, May 19, 2009 / Notices Application No. Drug Applicant 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 19454 ANDA 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 48220 ANDA 81–095 Acetaminophen, Aspirin, and Codeine Phosphate Capsules, 150 mg/180 mg/15 mg Mikart, Inc., 1750 Chattahoochee Ave., Atlanta, GA 30318 ANDA 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 19136 ANDA 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. mstockstill on PROD1PC66 with NOTICES 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 VerDate Nov<24>2008 16:48 May 18, 2009 Jkt 217001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Annual Survey of Refugees (Form ORR–9). OMB No.: 0970–0033. Description: The Annual Survey of Refugees collects information on the social and economic circumstances of a random sample of refugees, Amerasians, and entrants who arrived in the United States in the five years prior to the date PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 of the survey. The survey focuses on the refugees training, labor force participation, and welfare utilization rates. Dates are segmented by region of origin, State of resettlement, and number of months since arrival. From the responses, the Office of Refugee Resettlement reports on the economic adjustment of refugees to the American economy. These data are used by Congress in its annual deliberations for refugee admissions and funding and by program managers in formulating policies for the future direction of the Refugee Resettlement Program. Respondents: Refugees, entrants, Amerasians, and Havana parolees. E:\FR\FM\19MYN1.SGM 19MYN1

Agencies

[Federal Register Volume 74, Number 95 (Tuesday, May 19, 2009)]
[Notices]
[Pages 23407-23412]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11628]


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

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
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