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Aurobindo Pharma Ltd. et al.; Withdrawal of Approval of Eighty-Six Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of 86 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Effective Date: July 21, 2014.

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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.

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The holders of the applications listed in table 1 in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.

Table 1

Application No.DrugApplicant
ANDA 065395Cefazolin for Injection USP, 500 milligrams (mg) and 1 gram (g)Aurobindo Pharma Ltd., c/o AuroMedics Pharma LLC, 6 Wheeling Rd. Dayton, NJ 08810.
ANDA 065481Ceftazidime for Injection USP, 500 mg, 1 g, and 2 g  Do.
ANDA 065482Ceftazidime for Injection USP, 6 g  Do.
ANDA 065504Ceftriaxone for Injection USP, 10 g  Do.
ANDA 065505Ceftriaxime for Injection, 250 mg, 500 mg, 1 g, and 2 g  Do.
ANDA 065516Cefotaxime for Injection USP, 10 g  Do.
ANDA 065517Cefotaxime for Injection USP  Do.
ANDA 077467Nateglinide Tablets, 60 mg and 120 mgTeva Pharmaceuticals USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454.
ANDA 077472Cetirizine Hydrochloride (HCl) Syrup, 5 mg/5 milliliters (mL)Ranbaxy Laboratories Limited, c/o Ranbaxy Inc., 600 College Rd. East, Princeton, NJ 08540.
ANDA 077540Zolpidem Tartrate Tablets, 5 mg and 10 mgSynthon Pharmaceuticals, Inc., 9000 Development Dr., P.O. Box 110487, Research Triangle Park, NC 27709.
ANDA 077717Ondansetron Orally Disintegrating Tablets USP, 4 mg and 8 mgNesher Pharmaceuticals (USA) LLC, 13910 St. Charles Rock Rd., Bridgeton, MO 63044.
ANDA 077730Pravastatin Sodium Tablets, 10 mg, 20 mg, 30 mg, 40 mg, and 80 mgPliva HRVATSKA, c/o Barr Laboratories, Inc., 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 077826Fenoldopam Mesylate Injection USP, 10 mg (base)/mLTeva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 92618.
ANDA 077888Ciprofloxacin Injection USP, 2 mg/mLBaxter Healthcare Corp., 1620 Waukegan Rd., McGaw Park, IL 60085.
ANDA 077905Topiramate Tablets, 25 mg, 50 mg, 100 mg, and 200 mgPliva HRVATSKA, c/o Barr Laboratories, Inc.
ANDA 078016Zolpidem Tartrate Tablets, 5 mg and 10 mgMylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26505-4310.
ANDA 078053Sertraline HCl Oral Concentrate, 20 mg/mLRanbaxy Laboratories Limited, c/o Ranbaxy Inc.
ANDA 078114Ciprofloxacin Injection USP in 5% Dextrose, 2 mg/mLBedford Laboratories, 300 Northfield Rd., Bedford, OH 44146.
ANDA 078132Ibuprofen Tablets USP, 400 mg, 600 mg, and 800 mgQuality Regulatory Consultants, U.S. Agent for Northstar Healthcare Holdings, 501 Ivy Lake Dr., Forest, VA 24551.
ANDA 078187Risperidone Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mgSynthon Pharmaceuticals, Inc.
ANDA 078322Anastrozole Tablets, 1 mg  Do.
ANDA 078448Ranitidine HCl Solution, 15 mg/mLRanbaxy Inc., U.S. Agaent for Ranbaxy Laboratories Limited.
ANDA 078606Mitoxantrone Injection USPWashington Food and Drug Consultants, U.S. Agent for Fresenius Kabi Oncology Plc., 3631 Martins Dairy Circle, Olney, MD 20832.
ANDA 080043Nitrofurantoin Tablets, 50 mg and 100 mgSandoz Inc., 2555 W. Midway Blvd., Broomfield, CO 80038-0446.
ANDA 080203Potassium Chloride Injection USP, 2 milliequivalents/mLBaxter Healthcare Corp., 25212 W. IL Route 120, Round Lake, IL 70073.
ANDA 080642Hydrocortisone Tablets, 20 mgSandoz Inc.
ANDA 081142Aminophylline Injection USP, 25 mg/mLTeva Parenteral Medicines, Inc.
ANDA 081169Glycopyrrolate Injection USP, 0.2 mg/mL  Do.
ANDA 081266Methyprednisolone Sodium Succinate for Injection USP, 125 mg  Do.
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ANDA 081267Methylprednisolone Sodium Succinate for Injection USP, 500 mg  Do.
ANDA 081268Methyprednisolone Sodium Succinate for Injection USP, 1 g  Do.
ANDA 081278Leucovorin Calcium for Injection, 50 mg/vial  Do.
ANDA 083254Halothane USPHospira, Inc., 275 North Field Dr., Lake Forest, IL 60045.
ANDA 083263Alcohol in Dextrose Injection USP, 5%/5%  Do.
ANDA 083306Niacin Tablets, 50 mgSandoz Inc.
ANDA 083486Isoproterenol HCl Injection USP, 0.2 mg/mLBaxter Healthcare Corp.
ANDA 084051Dextroamphetamine Sulfate Tablets USP, 5 mg and 10 mgShire Development Inc., 725 Chesterbrook Blvd., Wayne, PA 19087.
ANDA 084233Promethazine HCl Tablets, 12.5 mgSandoz Inc.
ANDA 084472Folic Acid Capsules, 1 mg  Do.
ANDA 084827Hydrochlorothiazide and Reserpine Tablets, 25 mg/0.125 mg  Do.
ANDA 085034Phendimetrazine Tartrate Tablets, 35 mg  Do.
ANDA 085133Imipramine HCl Tablets, 50 mg  Do.
ANDA 085200Imipramine HCl Tablets, 10 mg  Do.
ANDA 085213Hydrochlorothiazide and Reserpine Tablets, 50 mg/0.125 mg  Do.
ANDA 085302Estrogens, Esterified Tablets, 1.25 mg  Do.
ANDA 085362Novocaine (procaine HCl Injection USP)Hospira, Inc.
ANDA 085370Dextroamphetamine Sulfate Tablets, 5 mgSandoz Inc.
ANDA 085371Dextroamphetamine Sulfate Tablets, 10 mg  Do.
ANDA 085402Phendimetrazine Tartrate Tablets, 35 mg  Do.
ANDA 085601Triamcinolone Tablets, 4 mg  Do.
ANDA 085633Phendimetrazine Tartrate Capsules, 35 mg  Do.
ANDA 085671Phentermine HCl Tablets, 8 mg  Do.
ANDA 085689Phentermine HCl Tablets USP, 8 mg  Do.
ANDA 085694Phendimetrazine Tartrate Capsules, 35 mg  Do.
ANDA 085702Phendimetrazine Tartrate Capsules, 35 mg  Do.
ANDA 085830Phendimetrazine Tartrate Tablets, 35 mg  Do.
ANDA 085852A-Methapred (methylprednisolone sodium succinate for injection USP), 1,000 mg/vialHospira, Inc.
ANDA 085853A-Methapred (methylprednisolone sodium succinate for injection USP), 40 mg/vial  Do.
ANDA 085854A-Methapred (methylprednisolone sodium succinate for injection USP), 500 mg/vial  Do.
ANDA 085929A-Hydrocort (hydrocortisone sodium succinate for injection USP), 100 mg/vialHospira, Inc.
ANDA 085930A-Hydrocort (hydrocortisone sodium succinate for injection USP), 250 mg/vial  Do.
ANDA 085931A-Hydrocort (hydrocortisone sodium succinate for injection USP), 500 mg/vial  Do.
ANDA 085932A-Hydrocort (hydrocortisone sodium for injection USP), 1,000 mg/val  Do.
ANDA 086370Phendimetrazine Tartrate Tablets, 35 mgSandoz Inc.
ANDA 086589Barbidonna Tablets (phenobarbital, hyoscyamine sulfate, scopolamine hydrobromide, and atropine sulfate)Meda Pharmaceuticals, Meda Pharmaceuticals, Inc., 265 Davidson Ave., Suite 300, Somerset, NJ 08873-4120.
ANDA 086590Barbidonna Elixir (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide)  Do.
ANDA 086664Butibel Elixir (sodium butabarbital and belladonna extract), 15 mg/5 mL and 15 mg/5 mL  Do.
ANDA 087208Phentermine HCl Capsules, 30 mgSandoz Inc.
ANDA 087223Phentermine HCl Capsules, 30 mg  Do.
ANDA 087759Prochlorperazine Edisylate Injection USPBaxter Healthcare Corp.
ANDA 087572Barbidonna No. 2 Tablets (phenobarbital, hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide) 32 mg, 0.1286 mg, 0.025 mg, and 0.0074 mgMeda Pharmaceuticals.
ANDA 088099Heparin Lock Flush Solution USP, 2,500 units/MlHospira, Inc.
ANDA 088175Chlorpropamide Tablets, 100 mgPar Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977.
ANDA 088176Chlorpropamide Tablets, 250 mg  Do.
ANDA 088184Hydroxyzine HCl Injection USP, 25 mg/mLFresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
ANDA 088185Hydroxyzine HCl Injection USP, 50 mg/mL  Do.
ANDA 0883301.5% Lidocain HCl Injection USPHospira, Inc.
ANDA 089158Methotrexate Injection USP, 25 mg/mLPharmachemie B.V., c/o Teva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 92618.
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ANDA 089420Azdone Tablets (hydrocodone bitartrate 5 mg and aspirin 500 mg)Schwarz Pharma, Inc., c/o UCB, Inc., 1950 Lake Park Dr., Smyrna, GA 30080.
ANDA 090183Cetirizine HCl Syrup, 5 mg/5mLRanbaxy Laboratories Limited, c/o Ranbaxy Inc.
ANDA 090196Letrozole Tablets USP, 2.5 mgSynthon Pharmaceuticals, Inc.
ANDA 090464Mycophenolate Mofetil Tablets, 500 mgDr. Reddy's Laboratories Limited, c/o Dr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd., 7th Floor, Bridgewater, NJ 08807.
ANDA 090567Polyethylene Glycol 3350 Powder for Oral SolutionPaddock Laboratories, LLC, a Perrigo Co., 3940 Quebec Ave. North, Minneapolis, MN 55427.
ANDA 090712Polyethylene Glycol 3350 and Electrolytes for Oral Solution  Do.
ANDA 090769Clenz-Lyte (polyethylene glyol 3350 and electrolytes for oral solution)  Do.
ANDA 091315Mycophenolalte Mofetil Capsules USP, 250 mgDr. Reddy's Laboratories Limited, c/o Dr. Reddy's Laboratories, Inc.

Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in table 1 in this document, and all amendments and supplements thereto, is hereby withdrawn, effective July 21, 2014. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the FD&C Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that are in inventory on the date that this notice becomes effective (see the DATES section) may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.

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Dated: June 13, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2014-14288 Filed 6-18-14; 8:45 am]