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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2012-N-0190]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 35 new drug applications (NDAs) and 64 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 Date:*
                         April 18, 2012.
 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 table 1 in this document have informed 
                    ( print page 16040)
                    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.
Drug
ApplicantNDA 005545
Dicumarol Tablets
Abbott Laboratories, PA77/Bldg. AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157.NDA 005845
Benadryl (diphenhydramine hydrochloride (HCl)), Benadryl with Ephedrine Sulfate, and Caladryl (diphenhydramine HCl and calamine)
McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., 7050 Camp Hill Rd., Fort Washington, PA 19034-2299.NDA 006146
Benadryl (diphenhydramine HCl)) Injection
Do.NDA 006773
Artane (trihexyphenidyl HCl) Tablets and Capsules and Artane (trihexyphenidyl) Elixir
Lederle Laboratories, d/b/a Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299.NDA 009486
Benadryl (diphenhydramine HCl)) Injection Preservative Free
McNeil Consumer Healthcare.NDA 010021
Placidyl (ethchlorvynol) Capsules
Abbott Laboratories, 200 Abbott Park Rd., Abbott Park, IL 60064.NDA 011552
Stelazine (trifluoperazine HCl)
GlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709-3398.NDA 012524
Enduron (methyclothiazide) Tablets, 2.5 milligrams (mg) and 5 mg
Abbott Laboratories, PA77/Bldg. AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157.NDA 012775
Enduronyl and Enduronyl Forte (methyclothiazide and deserpidine) Tablets
Do.NDA 014684
Aventyl (nortriptyline HCl) Capsules
Eli Lilly and Co., Lilly Corp. Center, Indianapolis, IN 46285.NDA 017577
Ditropan (oxybutynin chloride) Tablets
Janssen Pharmaceuticals Inc., c/o Johnson & Johnson Pharmaceutical Research and Development, LLC, 920 Route 202, P.O. Box 300, Raritan, NJ 08869.NDA 018473
Ventolin (albuterol) Inhalation Aerosol1
GlaxoSmithKline.NDA 018557
Fansidar (sulfadoxine and pyrimethamine) Tablets, 500 mg and 25 mg
Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199.NDA 018709
Capozide (captopril and hydrochlorothiazide) Tablets
Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000.NDA 018814
Heparin Sodium in 5% Dextrose Injection
Baxter Healthcare Corp., 1620 Waukegan Rd., MPGR-AL, McGaw Park, IL 60085.NDA 019297
Novantrone (mitoxantrone HCl) Injection
EMD Serono, One Technology Place, Rockland, MA 02370.NDA 019508
Axid (nizatidine) Capsules
SmithKline Beecham Corp., d/b/a GlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709-3398.NDA 019915
Monopril (fosinopril sodium) Tablets, 10 mg, 20 mg, and 40 mg
Bristol-Myers Squibb Co.NDA 019946
Nuromax (doxacurium chloride) Injection 1 mg/milliliter (mL)
Abbott Laboratories, P76/Bldg. AP30-1E, Abbott Park, IL 60064-6157.NDA 019960
Manoplax (flosequinan) Tablets
Do.NDA 020057
Ceredase (alglucerase) Injection
Genzyme Corp., 500 Kendall St., Cambridge, MA 02142.NDA 020088
Norplant System (levonorgestrel) Implants
Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101-8299.NDA 020101
Prozac (fluoxetine HCl) Oral Solution, 20 mg/5 mL
Eli Lilly and Co.NDA 020236
Serevent (salmeterol xinafoate) Inhalation Aerosol1
GlaxoSmithKline.NDA 020286
Monopril-HCT (fosinopril sodium and hydrochlorothiazide) Tablets, 20 mg/12.5 mg and 10 mg/12.5 mg
Bristol-Myers Squibb Co.NDA 020403
Zofran (ondansetron HCl) Injection
Glaxo Wellcome Manufacturing Pte Limited, d/b/a GlaxoSmithKline, 1250 Collegeville Rd., UP4110, Collegeville, PA 19426.NDA 020627
Norplant II System (levonorgestrel) Implants
Wyeth Pharmaceuticals, Inc.NDA 020828
Fortovase (saquinavir) Capsules, 200 mg
Hoffman-La Roche, Inc.NDA 020860
Levlite (ethinyl estradiol and levonorgestrel) Tablets
Bayer HealthCare Pharmaceuticals Inc., P.O. Box 1000, Montville, NJ 07045.NDA 020984
Raplon (rapacuronium bromide) for Injection
Organon USA Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.NDA 021120
Novantrone (mitoxantrone HCl) Injection
EMD Serono.NDA 021793
Reglan ODT (metoclopramide) Tablets
Meda Pharmaceuticals Inc., 200 North Cobb Parkway, Suite 428, Marietta, GA 30062.ANDA 040207
Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg
Duramed Pharmaceuticals, Inc., 400 Chestnut Rd., Woodcliff Lake, NJ 07677.ANDA 040231
Chlorpromazine HCl Oral Concentrate USP, 30 mg/mL
Pharmaceutical Associates, Inc., 201 Delaware St., Greenville, SC 29605.NDA 050526
Staticin (erythromycin) Topical Solution, 1.5%
Bristol-Myers Squibb Co.( print page 16041)NDA 050687
Banan (cefpodoxime proxetil) Tablets, 100 mg and 200 mg
Daiichi Sankyo, Inc., 399 Thornall St., 11th Floor, Edison, NJ 08837.NDA 050688
Banan (cefpodoxime proxetil) Granules for Oral Suspension, 50 mg/5 mL and 100 mg/5 mL
Do.ANDA 064098
Amikacin Sulfate Injection USP, 250 mg (base)/mL
Hospira, Inc., 275 North Field Dr., Bldg. H2-2, Lake Forest, IL 60045.ANDA 064106
Mitomycin for Injection USP, 20 mg Vial
Do.ANDA 070505
Metoclopramide Injection USP, 5 mg/mL
Do.ANDA 070506
Metoclopramide Injection USP, 5 mg/mL
Do.ANDA 070566
Nitropress (sodium nitroprusside for Injection USP), 50 mg
Do.ANDA 071015
Haloperidol Oral Solution USP, 2 mg/mL
Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454.ANDA 071554
Thiothixene HCl Oral Solution USP, 5 mg/mL
Do.ANDA 073058
Fluphenazine HCl Oral Solution USP, 5 mg/mL
Do.ANDA 073479
Pentamidine Isethionate for Injection, 300 mg Vial
Hospira, Inc.ANDA 074636
Iopamidol Injection USP, 41%, 51%, 61%, 76%
Do.ANDA 074898
Iopamidol Injection USP, 41%, 51%, 61%, 76%
Do.ANDA 075065
Acyclovir Sodium for Injection
Do.ANDA 075176
Haloperidol Decanoate Injection, 50 mg/mL and 100 mg/mL
Do.ANDA 075409
Midazolam HCl Injection, 1 mg (base)/mL and 5 mg (base)/mL
Do.ANDA 075884
Milrinone Lactate Injection, 1 mg/mL
Do.ANDA 076306
Topiramate Tablets, 25 mg, 50 mg, 100 mg, and 200 mg
Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228.ANDA 077138
Ciprofloxacin Injection USP in 5% Dextrose Injection
Teva Pharmaceuticals USA.ANDA 077223
Terbinafine HCl Tablets, 250 mg (base)
Roxane Laboratories, Inc.ANDA 077784
Risperidone Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg
Ratiopharm Inc., c/o Columbia Pharma Consulting Services Inc., 490 Northwest Datewood Dr., Suite 400, Issaquah, WA 98027.ANDA 078241
Sumatriptan Succinate Tablets, 25 mg, 50 mg, and 100 mg (base)
Roxane Laboratories, Inc.ANDA 078318
Sumatriptan Injection, 4 mg (base)/0.5 mL and 6 mg (base)/0.5 mL
TEVA Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 92618.ANDA 078416
Prednisolone Sodium Phosphate Oral Solution, 5 mg (base)/5 mL
Vintage Pharmaceuticals, 120 Vintage Dr., Huntsville, AL 35811.ANDA 078517
Venlafaxine HCl Tablets, 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base), and 100 mg (base)
PLIVA Hrvatska d.o.o., c/o Barr Laboratories, Inc., 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677ANDA 080997
Succinylcholine Chloride Injection USP, 20 mg/mL
Organon USA Inc.ANDA 081125
Dexamethasone Sodium Phosphate Injection USP, 4 mg/mL
TEVA Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 92618.ANDA 081126
Dexamethasone Sodium Phosphate Injection USP
Do.ANDA 081298
Chlorzoxazone Tablets, 250 mg
Ranbaxy Inc., U.S. Agent for Ohm, 600 College Rd. East, Princeton, NJ 08540.ANDA 081299
Chlorzoxazone Tablets, 500 mg
Do.ANDA 081310
Fluphenazine HCl Elixir USP, 2.5 mg/5 mL
Teva Pharmaceuticals USA.ANDA 087005
Trichlormethiazide Tablets, 4 mg
Par Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977.ANDA 087007
Trichlormethiazide Tablets, 2 mg
Do.ANDA 087032
Chlorpromazine HCl Oral Concentrate USP, 30 mg/mL
Morton Grove Pharmaceuticals, Inc., U.S. Agent for Wockhardt EU Operations (Swiss) AG, 6451 West Main St., Morton Grove, IL 60053.ANDA 087053
Chlorpromazine HCl Oral Concentrate USP, 100 mg/mL
Do.ANDA 087406
Oxycodone and Acetaminophen Tablets USP, 5 mg/325 mg
Barr Laboratories, Inc., 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.ANDA 087585
Potassium Chloride for Injection Concentrate USP, 2 mEq/mL
Luitpold Pharmaceuticals, Inc., One Luitpold Dr., P.O. Box 9001, Shirley, NY 11967.ANDA 088143
Trifluoperazine Oral Solution USP, 10 mg/mL
Morton Grove Pharmaceuticals, Inc., U.S. Agent for Wockhardt EU Operations (Swiss) AG.ANDA 088194
Thioridazine HCl Tablets USP, 50 mg
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.ANDA 088227
Thioridazine HCl Oral Solution USP (Concentrate), 100 mg/mL
Morton Grove Pharmaceuticals, Inc., U.S. Agent for Wockhardt EU Operations (Swiss) AG.ANDA 088258
Thioridazine HCl Oral Solution USP (Concentrate), 30 mg/mL
Do.ANDA 088270
Thioridazine HCl Tablets USP, 10 mg
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA.ANDA 088271
Thioridazine HCl Tablets USP, 15 mg
Do.( print page 16042)ANDA 088272
Thioridazine HCl Tablets USP, 25 mg
Do.ANDA 088273
Thioridazine HCl Tablets USP, 100 mg
Do.ANDA 088456
Thioridazine HCl Tablets USP, 100 mg
Teva Pharmaceuticals USA.ANDA 088493
Thioridazine HCl Tablets USP, 10 mg
Do.ANDA 088850
Hydroflumethiazide Tablets USP, 50 mg
Par Pharmaceutical, Inc.ANDA 088907
Reserpine and Hydroflumethiazide Tablets, 0.125 mg/50 mg
Do.ANDA 088933
Sulfinpyrazone Tablets, 100 mg
Do.ANDA 088934
Sulfinpyrazone Capsules USP, 200 mg
Do.ANDA 089135
Methyclothiazide Tablets, 2.5 mg
Do.ANDA 089136
Methyclothiazide Tablets, 5 mg
Do.ANDA 089173
A-MethaPred (methylprednisolone sodium succinate for injection USP), 500 mg (base)/Vial
Hospira, Inc.ANDA 089174
A-MethaPred (methylprednisolone sodium succinate for injection USP), 1 gram (base)/Vial
Do.ANDA 089207
Methylprednisolone Tablets USP, 16 mg
Par Pharmaceutical, Inc.ANDA 089208
Methylprednisolone Tablets USP, 24 mg
Do.ANDA 089209
Methylprednisolone Tablets USP, 32 mg
Do.ANDA 089457
Perphenazine Tablets USP, 16 mg
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA.ANDA 089602
Thioridazine HCl Oral Solution USP, 30 mg/mL
Teva Pharmaceuticals USA.ANDA 089603
Thioridazine HCl Oral Solution USP, 100 mg/mL
Do.ANDA 089624
Reversol (edrophonium chloride injection USP), 10 mg/mL)
Organon USA Inc.ANDA 089657
Methocarbamol and Aspirin Tablets, 400 mg/325 mg
Par Pharmaceutical, Inc.ANDA 089708
Perphenazine Tablets USP, 4 mg
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA.1
                         This product included an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no longer be used as a propellant for any albuterol or salmeterol metered-dose inhalers (see 70 FR 17168, April 4, 2005; 71 FR 70870, December 7, 2006).
 Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (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 April 18, 2012. 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 in this document 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. Dated: February 16, 2012. Janet Woodcock, Director, Center for Drug Evaluation and Research.


[FR Doc. 2012-6591 Filed 3-16-12; 8:45 am] BILLING CODE 4160-01-P