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Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of 121 new drug applications (NDAs) and 161 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


The withdrawal is effective on July 21, 2017.

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Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, 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.Start Printed Page 28323

Table 1

Application No.DrugApplicant
NDA 005897Folvite (folic acid) Injection, 5 milligrams (mg)/milliliter (mL)Wyeth Pharmaceuticals Inc., Subsidiary of Pfizer Inc., P.O. Box 8299, Philadelphia, PA 19101-8299.
NDA 006343Wydase (hyaluronidase) Injection USPBaxter Healthcare Corp., 32650 N. Wilson Rd., Round Lake, IL 60073.
NDA 007390Banthine (methantheline bromide) Tablets, 50 mgShire Development Inc., 725 Chesterbrook Blvd., Wayne, PA 19087.
NDA 008126Cortisone Acetate (cortisone acetate) Tablets, 5 mg, 10 mg, and 25 mg; and Injection, 25 mg/mLPharmacia & Upjohn Co., Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017.
NDA 008732Pro-Banthine (propantheline bromide) Tablets, 7.5 mg and 15 mgShire Development Inc.
NDA 011683Thiotepa for Injection, 15 mg/vialImmunex Corp., Subsidiary of Amgen, 1 Amgen Center Dr., MS 17 1B, Thousand Oaks, CA 91320-1799.
NDA 011836Presamine (imipramine hydrochloride (HCl)) Tablets USPSanofi-Aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ 08807.
NDA 012003Akineton (biperiden HCl) Tablets, 2 mgAbbVie Inc., 1 N. Waukegan Rd., Dept. PA77/Bldg. AP30-1, North Chicago, IL 60064.
NDA 012421Medrol Acetate (methylprednisolone acetate) Topical Ointment, 0.25% and 1%Pharmacia & Upjohn Co.
NDA 013935Herplex (idoxuridine) Ophthalmic Solution, 0.1%Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623-9534.
NDA 013993Chromitope Sodium (sodium chromate Cr 51) Injection USP, 2 millicuries (mCi)/vial and 200 microcuries (uCi)/mLBracco Diagnostics Inc., 259 Prospect Plains Rd., Bldg. H, Monroe Township, NJ 08831.
NDA 014006Maxibolin (ethylestrenol) Elixir, 2 mg/5 mLOrganon USA, Inc., Subsidiary of Merck & Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.
NDA 014214NegGram (nalidixic acid) Tablets USP, 250 mg, 500 mg, and 1 gram (g)Sanofi-Aventis U.S. LLC, c/o Sanofi U.S. Services Inc., 55 Corporate Dr., Bridgewater, NJ 08807.
NDA 014295Conray 400 (iothalamate sodium) Injection USP, 66.8%Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO 63042.
NDA 016089Rubratope-57 (cyanocobalamin CO-57) Capsules, 0.5-1 uCi and Rubratope-57 Kit (cobalt chloride CO-57, cyanocobalamin, cyanocobalamin CO-57, intrinsic factor)Bracco Diagnostics Inc.
NDA 016672Ovral (ethinyl estradiol and norgestrel) Tablets, 0.05 mg/0.5 mgWyeth Pharmaceuticals Inc.
NDA 016692M/6 Sodium Lactate (sodium lactate) Injection USP, 1.87 g/100 mLBaxter Healthcare Corp.
NDA 016696Dextrose 10% and Sodium Chloride 0.9% Injection USP in Plastic Container  Do.
NDA 016708Sodium Chromate Cr 51 Injection, 100 µCi/mLMallinckrodt Nuclear Medicine LLC., 2703 Wagner Place, Maryland Heights, MO 63043.
NDA 016744Noriday 1+50 FE (mestranol and norethindrone) TabletsGD Searle LLC, Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017.
NDA 016806Ovral-28 (ethinyl estradiol and norgestrel) Tablets, 0.05 mg/0.5 mgWyeth Pharmaceuticals Inc.
NDA 016860Eskalith (lithium carbonate) Capsules, 300 mgNoven Therapeutics, LLC., 11960 Southwest 144th St., Miami, FL 33186.
NDA 017038Sodium Chloride Injection, 20 g/100 mLB. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 18109.
NDA 017281Technetium Tc99m Generator (Neutron)Lantheus Medical Imaging, Inc., 331 Treble Cove Rd., North Billerica, MA 01862.
NDA 017283Xenon Xe 133 Injection, 6.3 mCi/mLLantheus Medical Imaging, Inc.
NDA 017505Noriday (mestranol and norethindrone) TabletsGD Searle LLC.
NDA 017549LidoPen (lidocaine HCl) Injection, 10%Meridian Medical Technologies, Inc., Subsidiary of Pfizer Inc., 235 East 42nd Street, New York, NY 10017.
NDA 017576Ovcon-50 (ethinyl estradiol and norethindrone ) Tablets USP, 0.05 mg/1 mgWarner Chilcott Co., LLC, Union Street Road, 195 km 1.1, Fajrado, Puerto Rico 00738.
NDA 017670Sodium Chloride 0.45% in Plastic Container, IrrigationHospira, Inc. 275 North Field Dr., Lake Forest, IL 60045.
NDA 017756Tylenol (acetaminophen) Suppositories, 120 mg and 650 mgJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, 7050 Camp Hill Rd., Fort Washington, PA 19034.
NDA 017748Noriday 1+50 (mestranol and norethindrone) TabletsGD Searle LLC.
NDA 018031Inderide (propranolol HCl and hydrochlorothiazide) Tablets, 40 mg/25 mg and 80 mg/25 mgWyeth Pharmaceuticals Inc.
NDA 018039Loxitane IM (loxapine HCl) Injection, Equivalent to (EQ) 50 mg base/mLActavis Laboratories UT, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Road, Horsham, PA 19044.
NDA 018104Hylorel (guanadrel sulfate) Tablets, 10 mg and 25 mgPharmacia and Upjohn Co.
NDA 018239Propine (dipivefrin HCl) Ophthalmic Solution USP, 0.1%Allergan, Inc.
NDA 018254Ringer's and Dextrose 5% (calcium chloride, dextrose, potassium chloride, sodium chloride) Injection USP (in Plastic Container)Hospira Inc.
NDA 018353Flagyl I.V. (metronidazole HCl) for Injection, EQ 500 mg base/vialGD Searle LLC.
NDA 018388Lidocaine HCl in Dextrose 5% in Plastic Container InjectionHospira, Inc.
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NDA 0184040.25% Acetic Acid Irrigation Solution  Do.
NDA 018406PhysioSol (magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium gluconate) Irrigation Solution  Do.
NDA 018460Dialyte (Peritoneal Dialysis Solution) Pattern LM (calcium chloride, dextrose, magnesium chloride, sodium acetate, sodium chloride) with DextroseB. Braun Medical Inc.
NDA 018465Soyacal (soybean oil) Injection, 10%Grifols Biologicals Inc., 5555 Valley Blvd., Los Angeles, CA 90032.
NDA 018509Baros (sodium bicarbonate, tartaric acid) Effervescent Granules, 460 mg/g; 420 mg/g)Mallinckrodt Inc.
NDA 018713Mycelex (clotrimazole) Troche/Lozenge, 10 mgBayer Healthcare Pharmaceuticals Inc., 100 Bayer Blvd., Whippany, NJ 07981.
ANDA 018730Indomethacin Capsules USP, 25 mg and 50 mgZenith Laboratories, Inc., 140 LeGrand Ave., Northvale, NJ 07647.
NDA 018786Soyacal(Soybean Oil) Injection, 20%Grifols Biologicals Inc., 5555 Valley Blvd., Los Angeles, CA 90032.
NDA 018807Dialyte (Peritoneal Dialysis Concentrates) (calcium chloride, dextrose, magnesium chloride, sodium acetate, sodium chloride) with DextroseB. Braun Medical Inc.
NDA 018887Intal (cromolyn sodium) Metered Dose Inhaler, 0.8 mg/inhalationKing Pharmaceuticals Inc., Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017.
NDA 018970Liposyn III 20% (soybean oil) InjectionHospira, Inc.
NDA 018991Liposyn II 20% (safflower oil and soybean oil) Injection  Do.
NDA 018997Liposyn II 10% (safflower oil and soybean oil) Injection  Do.
NDA 019038Calan (verapamil HCl) Injection, 2.5 mg/mLG.D. Searle LLC.
NDA 019121Bretylium Tosylate in 5% Dextrose InjectionB. Braun Medical Inc.
NDA 019212Theophylline and 5% Dextrose Injection  Do.
NDA 019229Zinc Sulfate Injection, EQ 1 mg Zinc/mLAbraxis Pharmaceutical Products, 6133 North River Rd., Suite 500, Rosemont, IL 60018.
NDA 019350Cupric Sulfate Injection, EQ 0.4 mg Copper/mL  Do.
NDA 019415Fertinex (urofollitropin) for Subcutaneous Injection, 75 international units (IU)/ampule and 150 IU/ampule, and Metrodin (urofollitropin) for Intramuscular Injection, 75 IU)/ampule and 150 IU/ampuleEMD Serono, Inc., One Technology Pl., Rockland, MA 02370.
NDA 019510Pepcid (famotidine) Injection, 10 mg/mLMerck Sharp & Dohme Corp., Subsidiary of Merck & Co., Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889.
NDA 019514Ionosol T and 5% Dextrose InjectionHospira, Inc.
NDA 019515Ionosol B and 5% Dextrose Injection  Do.
NDA 019641Terazol 3 (terconazole) Vaginal Suppositories, 80 mgJanssen Pharmaceuticals, Inc., 1000 U.S. Highway 202, Raritan, NJ 08869.
NDA 019643Mevacor (lovastatin) Tablets, 10 mg, 20 mg, and 40 mgMerck Sharp & Dohme Corp.
NDA 019660Tilade (nedocromil sodium) Metered Dose Inhaler, 1.75 mg/inhalationKing Pharmaceuticals Inc.
NDA 019793Pharmaseal Scrub Care (chlorhexidine gluconate) Sponge, 4%CareFusion 2200, Inc., 75 North Fairway Dr., Vernon Hills, IL 60061.
NDA 019802Heparin Sodium in Sodium Chloride InjectionB. Braun Medical Inc.
NDA 019834Plendil (felodipine) Extended-Release Tablets, 2.5 mg, 5 mg, and 10 mgAstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803.
NDA 019907Optipranolol (metipranolol HCl) Ophthalmic Solution, 0.3%Bausch & Lomb, Inc., Subsidiary of Valeant Pharmaceuticals International, Inc., 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
NDA 019933Lactated Ringer's (calcium chloride, potassium chloride, sodium chloride, sodium lactate) Irrigation SolutionBaxter Healthcare Corp.
NDA 020092Dilacor XR (diltiazem HCl) Extended-Release Capsules, 120 mg, 180 mg, and 240 mgAllergan Sales, LLC, 2525 Dupont Drive, Irvine, CA 92612.
NDA 020146Nitrodisc (nitroglycerin) Transdermal System, 0.2 mg/hour (hr), 0.3 mg/hr, and 0.4 mg/hrGD Searle LLC.
NDA 020181Liposyn III 30% (soybean oil) InjectionHospira, Inc.
NDA 020249Pepcid Preservative Free (famotidine) Injection, 0.4 mg/mLMerck Sharp & Dohme Corp.
NDA 020291Combivent (albuterol sulfate and ipratropium bromide) Metered Dose Inhaler, EQ 0.09 mg base/inhalation; 0.018 mg/inhalationBoehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877.
NDA 020292FerriSeltz (ferric ammonium citrate) Powder for Oral Solution, 600 mg/packetOtsuka Pharmaceutical Co., Ltd., 508 Carnegie Center Dr., Princeton, NJ 08540.
ANDA 020360Hepatasol Sulfite-free (amino acids) Injection, 8%Baxter Healthcare Corp.
NDA 020409Nasarel (flunisolide) Nasal Spray, 0.029 mg/sprayTeva Branded Pharmaceutical Products R&D, Inc., 74 NW 176th St., Miami, FL 33169.
NDA 020448Imodium A-D (loperamide HCl) Tablets (Chewable), 2 mgJohnson & Johnson Consumer Inc.
NDA 020506Tiamate (diltiazem malate) Extended-Release TabletsMerck & Co., Inc., P.O. Box 1000, UG2C-50, North Wales, PA 19454.
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NDA 020518Retrovir (zidovudine) Tablets, 200 mg and 300 mgViiV Healthcare Co., Five Moore Dr., P.O. Box 13398, Research Triangle Park, NC 27709.
NDA 020569Vitrasert (ganciclovir) Implant, 4.5 mgBausch & Lomb Inc.
NDA 020606Imodium Multi-Symptom Relief (loperamide HCl and simethicone) Tablets (Chewable), 2 mg/125 mgJohnson & Johnson Consumer Inc.
NDA 020635Levaquin (levofloxacin) Injection, EQ 250 mg/50 mL, EQ 500 mg/100 mL, and EQ 750 mg/150 mLJanssen Pharmaceuticals, Inc.
NDA 020745Zantac (ranitidine HCl) Tablets (Effervescent), EQ 75 mg baseSanofi-Aventis U.S. LLC, 55 Corporate Drive, Bridgewater, NJ 08807.
NDA 020752Pepcid RPD (famotidine) Orally Disintegrating Tablets, 20 mg and 40 mgMerck Sharp & Dohme Corp.
NDA 020799Floxin Otic (ofloxacin) Otic Solution, 0.3%Daiichi Sankyo Co., Ltd., 399 Thornall St., Edison, NJ 08837.
NDA 020813Klonopin (clonazepam) Orally Disintegrating Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 2 mgHoffmann La-Roche, Inc., c/o Genentech, Inc., 1 DNA Way MS #242, South San Francisco, CA 94080.
NDA 020902Pepcid AC (famotidine) Tablets OTC, 10 mgJohnson & Johnson Consumer Inc.
NDA 021097Visicol (sodium phosphate, monobasic monohydrate, and sodium phosphate dibasic anhydrous) Tablets USPSalix Pharmaceuticals Inc., Subsidiary of Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
NDA 021214Rescula (unoprostone isopropyl) Ophthalmic Solution, 0.15%R-Tech Ueno, Ltd., c/o Sucampo Pharma Americas, LLC, 805 King Farm Blvd., Suite 550, Rockville, MD 20850.
NDA 021224Razadyne (galantamine hydrobromide) Oral Solution, 4 mg/mLJanssen Pharmaceuticals, Inc.
NDA 021317Bayer Extra Strength Aspirin (aspirin) Tablets, 500 mgBayer Healthcare LLC, 100 Bayer Blvd., Whippany, NJ 07981.
NDA 021412Tovalt ODT (zolpidem tartrate) Orally Disintegrating Tablets, 5 mg and 10 mgValeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
NDA 021453Zerit XR (stavudine) Extended-Release Capsules, 37.5 mg, 50 mg, 75 mg, and 100 mgBristol-Myers Squibb Co., 5 Research Parkway, Wallingford, CT 06492.
NDA 021483Geodon (ziprasidone HCl) Oral Suspension, EQ10 mg base/mLPfizer Inc., 235 East 42nd St., New York, NY 10017.
NDA 021494Axid (nizatidine) Oral Solution, 15 mg/mLBraintree Laboratories, Inc., 60 Columbian St. West, P.O. Box 850929, Braintree, MA 02185.
NDA 021589Kemstro (baclofen) Orally Disintegrating Tablets, 10 mg and 20 mgUCB, Inc.,1950 Lake Park Dr., Smyrna, GA 30080.
NDA 021595Sanctura (trospium chloride) Tablets, 20 mgAllergan, Inc.
NDA 021721Levaquin (levofloxacin) Oral Solution, 25 mg/mLJanssen Pharmaceuticals, Inc.
NDA 021763Citalopram Hydrobromide Orally Disintegrating Tablets, EQ 10 mg base, EQ 20 mg base, and EQ 40 mg baseValeant International (Barbados) SRL Welches, Christ Church, Barbados, BB17154.
NDA 021864Lybrel (ethinyl estradiol and levonorgestrel) Tablets, 0.02 mg/0.09 mgWyeth Pharmaceuticals Inc.
NDA 022103Sanctura XR (trospium chloride) Extended-Release Capsules, 60 mgAllergan, Inc.
NDA 022220Trivaris (triamcinolone acetonide) Injectable Suspension, 80 mg/mL  Do.
NDA 022294Zidovudine Tablets, 60 mgAurobindo Pharma Limited, c/o Aurobindo Pharma USA, Inc., 2400 Route 130 North, Dayton, NJ 08810.
NDA 022377Alsuma (sumatriptan succinate) Auto-Injector, EQ 6 mg base/0.5 mL InjectableMeridian Medical Technologies, Inc., 1945 Craig Rd., St. Louis, MO 63146.
NDA 022411Oleptro (trazodone HCl) Extended-Release Tablets, 150 mg and 300 mgAngelini Pharma Inc., 8322 Helgerman Ct., Gaithersburg, MD 20877.
NDA 022494Sodium Fluoride F 18 Injection, 10-200 mCi/mLNational Institutes of Health/National Cancer Institute, Cancer Imaging Program, 9609 Medical Center Dr., Room 4-W236, MSC 9729, Bethesda, MD 20892-9729.
NDA 022545Tekamlo (aliskiren hemifumarate and amlodipine besylate) TabletsNovartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936.
ANDA 040032Cyclophosphamide Tablets USP, 25 mg and 50 mgRoxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228.
ANDA 040262Leucovorin Calcium for Injection, EQ 350 mg base/vialPharmachemie B.V., c/o SICOR Pharmaceuticals, Inc., 19 Hughes, Irvine, CA 92618.
ANDA 040772Fluorouracil Injection USP, 50 mg/mLSandoz Inc., 100 College Road West, Princeton, NJ 08540.
ANDA 040793A-Methapred (methylprednisolone sodium succinate) for Injection USP, EQ 40 mg base/vialHospira, Inc.
ANDA 040827A-Methapred (methylprednisolone sodium succinate) for Injection USP, EQ 125 mg base/vial  Do.
NDA 050182Erythrocin (erythromycin lactobionate) for Injection USP  Do.
NDA 050435Geocillin (carbenicillin indanyl sodium) Tablets, EQ 382 mg basePfizer, Inc.
NDA 050528Duricef (cefadroxil) Tablets USP, EQ 1 g baseWarner Chilcott Co., Inc., 100 Enterprise Drive, Rockaway, NJ 07866.
NDA 050545Pipracil (piperacillin sodium) InjectionWyeth Pharmaceuticals Inc.
NDA 050590Timentin (ticarcillin disodium and clavulanate potassium) for InjectionGlaxoSmithKline.
Start Printed Page 28326
NDA 050658Timentin Galaxy Plastic Container(ticarcillin disodium and clavulanate potassium) for Injection  Do.
NDA 050664Cefzil (cefprozil) Tablets, 250 mg and 500 mgCorden Pharma Latina, S.p.A. , c/o Clinipace, Inc., 4840 Pearl East Circle, Suite 210E, Boulder, CO 80301.
NDA 050665Cefzil (cefprozil) Oral Suspension, 125 mg/5 mL and 250 mg/5 mL  Do.
ANDA 060076Streptomycin Sulfate Powder for Injection, EQ 1 g base/vial and EQ 5 g base/vialPfizer Inc.
ANDA 060111Streptomycin Sulfate Powder for Injection, EQ 1 g base/2.5 mL  Do.
ANDA 060607Neomycin Sulfate Tablets, 500 mgLannett Co., Inc., 9000 State Rd., Philadelphia, PA 19136.
ANDA 061578Poly-Rx (polymyxin B sulfate USP) for Prescription CompoundingX-GEN Pharmaceuticals, Inc., 300 Daniel Zenker Dr., Horseheads, NY 14845.
ANDA 061580Baci-Rx (bacitracinUSP) for Prescription Compounding  Do.
ANDA 061645Econochlor (chloramphenicol) Ophthalmic Solution USP, 0.5%Alcon Laboratories, Inc., 6201 South Freeway, TC-45, Fort Worth, TX 76134-2099.
ANDA 061648Chloramphenicol Ophthalmic Ointment, 1%  Do.
ANDA 062118Cephalexin Capsules USP, EQ 250 mg base and EQ 500 mg base  Do.
ANDA 062206Cefaclor for Oral Suspension USP, EQ 125 mg base/5 mL, EQ 187 mg base/5 mL, EQ 250 mg base/5 mL, and EQ 375 mg base/5 mL  Do.
ANDA 062339Statrol (neomycin sulfate and polymyxin B sulfate) Ophthalmic Solution, EQ 3.5 mg base/mL and 16,250 units/mLAlcon Laboratories, Inc.
ANDA 062523Gentamicin Sulfate Ophthalmic Solution USP, EQ 0.3% base  Do.
ANDA 062628Chloramphenicol Ophthalmic Solution USP, 0.5%  Do.
ANDA 062691Timentin ADD-Vantage (ticarcillin disodium and clavulanate potassium) for Injection USP, EQ 3 g base/vial and EQ 100 mg base/vialGlaxoSmithKline.
ANDA 062714Neomycin Sulfate and Dexamethasone Sodium Phosphate Ophthalmic Solution, EQ 3.5 mg base/mL and EQ 0.1% andAlcon Pharmaceuticals Ltd., 6201 South Freeway, Fort Worth, TX 76134.
ANDA 062721Neomycin and Polymyxin B Sulfate and Dexamethasone Ophthalmic Suspension USP, EQ 3.5 mg base/mL; 10,000 units/mL; 0.1%  Do.
ANDA 062822Pediotic (neomycin sulfate and polymyxin B sulfate and hydrocortisone) Otic Suspension USPMonarch Pharmaceuticals, Inc., Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017-7555.
ANDA 063176Tobramycin Ophthalmic Solution USP, 0.3%Alcon Pharmaceuticals, Ltd.
ANDA 063208Cefazolin for Injection USP, EQ 1 g base/100 mL vialSteri-Pharma, LLC, 429 South West St., Syracuse, NY 13202.
ANDA 063216Cefazolin for Injection USP, EQ 500 mg base/100 mL vial  Do.
ANDA 063283Amikacin Sulfate Injection, EQ 62.5 mg base/mLHospira, Inc.
ANDA 064169Cefazolin for Injection USP, EQ 500 mg base/vial and EQ 1 g base/vialFresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
ANDA 064170Cefazolin for Injection USP, EQ 10 g base/vial and EQ 20 g base/vial  Do.
ANDA 065010Neo-Fradin (neomycin sulfate) Oral Solution USP, EQ 87.5 mg base/5 mLX-GEN Pharmaceuticals, Inc.
ANDA 065011Cefoxitin (cefoxitin sodium) for Injection, EQ 10 g base/VialFresenius Kabi USA, LLC.
ANDA 065012Cefoxitin for Injection USP, EQ 1 g base/vial and EQ 2 g base/vial  Do.
ANDA 065245Ceftriaxone for Injection USP, EQ 250 mg base/vial, EQ 500 mg base/vial, EQ 1 g base/vial, and EQ 2 g base/vial  Do.
ANDA 065252Ceftriaxone for Injection, EQ 10 g base/vial  Do.
ANDA 065324Amoxicillin Tablets for Oral Suspension USP, 200 mg and 400 mgAurobindo Pharma Limited.
ANDA 065339Epirubicin HCl Injection, 50 mg/25 mL and 200 mg/100 mLSandoz, Inc.
ANDA 065465Ceftriaxone for Injection USP, EQ 250 mg base/vial, EQ 500 mg base/vial, EQ 1 g base/vial, and EQ 2 g base/vialBedford Laboratories, c/o PAREXEL International, 4600 East-West Highway, Suite 350, Bethesda, MD 20814.
ANDA 065475Ceftriaxone for Injection USP, EQ 10 g base/vial  Do.
ANDA 070088Ibuprofen Tablets USP, 600 mgBASF Corp., 5738 County Rd. 4, Bishop, TX 78343.
ANDA 070187Disopyramide Phosphate Capsules USP, EQ 150 mg baseIvax Pharmaceuticals Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Road, Horsham, PA 19044.
ANDA 070587Bupivacaine HCl Injection USP, 0.75%Hospira, Inc.
ANDA 070659Clonidine HCl Tablets, 0.3 mgTeva Pharmaceuticals USA Inc., 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454.
ANDA 070702Clonidine HCl Tablets, 0.2 mg  Do.
ANDA 070747Clonidine HCl Tablets, 0.1 mg  Do.
ANDA 070804Metaproterenol Sulfate Inhalation Solution USP, 0.6%Mylan Specialty, L.P., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504.
ANDA 071067Methyldopa Tablets USP, 500 mgTeva Pharmaceuticals USA, Inc.
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ANDA 071101Clonidine HCl Tablets USP, 0.3 mgDuramed Pharmaceuticals, Inc., 2 Quaker Rd., P.O. Box 2900, Pomona, NY 10970.
ANDA 071102Clonidine HCl Tablets USP, 0.2 mg  Do.
ANDA 071103Clonidine HCl Tablets USP, 0.1 mg  Do.
ANDA 071105Methyldopa Tablets USP, 125 mgTeva Pharmaceuticals USA, Inc.
ANDA 071106Methyldopa Tablets USP, 250 mg  Do.
ANDA 071426Vincasar PFS (vincristine sulfate) Injection USP, 1 mg/mLTeva Parenteral Medicines Inc., 19 Hughes, Irvine, CA 92618.
ANDA 071584Diazepam Injection USP, 5 mg/mLHospira, Inc.
ANDA 071786Metaproterenol Sulfate Inhalation Solution USP, 0.4%Mylan Specialty L.P.
ANDA 072323Acetylcysteine Solution USP, 10%Roxane Laboratories, Inc.
ANDA 072324Acetylcysteine Solution USP, 20%  Do.
ANDA 073034Metaproterenol Sulfate Oral Solution USP, 10 mg/5 mLG&W Laboratories Inc., 111 Coolidge St., South Plainfield, NJ 07080.
ANDA 073636Dipivefrin HCl Ophthalmic Solution USP, 0.1%Alcon Pharmaceuticals, Ltd.
ANDA 073676Atenolol Tablets, 50 mg and 100 mgGD Searle LLC.
ANDA 074023Ranitidine Tablets USP, 150 mg and 300 mgMylan Pharmaceuticals Inc.
ANDA 074160Bumetanide Injection USP, 0.25 mg/mLHospira, Inc.
ANDA 074269Cimetidine in Sodium Chloride 0.9% Injection USP, EQ6 mg base/mL)  Do.
ANDA 074300Lorazepam Injection USP, 2 mg/mL and 4 mg/mL  Do.
ANDA 074396Enflurane Inhalation , 99.9%Piramal Critical Care, Inc., 3950 Schelden Circle, Bethlehem, PA 18017.
ANDA 074546Clozapine Tablets USP, 25 mg and 100 mgSandoz, Inc.
ANDA 074632Atracurium Besylate Injection, 10 mg/mLHospira, Inc.
ANDA 074851Levobunolol HCl Ophthalmic Solution USP, 0.25%Alcon Laboratories, Inc.
ANDA 074927Etodolac Tablets USP, 400 mgLehigh Valley Technologies, Inc., 514 North 12th St., Allentown, PA 18102.
ANDA 075117Orapred (prednisolone sodium phosphate) Oral Solution, EQ 15 mg base/5 mLConcordia Pharmaceuticals, Inc., c/o Mapi USA, Inc., 2343 Alexandria Dr., Suite 100, Lexington, KY 40504.
ANDA 075436Paclitaxel Injection USP, 6 mg/mLAccord Healthcare Inc., 1009 Slater Rd., Suite 210-B, Durham, NC 27703.
ANDA 075721Leuprolide Acetate Injection, 1 mg/0.2 mLGenzyme Corp., 500 Kendall St., Cambridge, MA 02142.
ANDA 075963Tramadol HCl Tablets, 50 mgIvax Pharmaceuticals Inc.
ANDA 076234Flavoxate HCl Tablets, 100 mgImpax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544.
ANDA 076296Vincristine Sulfate Injection USP, 1 mg/mLFresenius Kabi USA, LLC.
ANDA 076394Amiodarone HCl Injection, 50 mg/mLPar Sterile Products, LLC, Morris Corporate Center 2, One Upper Pond Rd., Parsippany, NJ 07054.
ANDA 076401Vincristine Sulfate Injection USP, 1 mg/mLFresenius Kabi USA, LLC.
ANDA 076414Milrinone Lactate in 5% Dextrose Injection, EQ 20 mg base/100 mLB. Braun Medical Inc.
ANDA 076563Diltiazem HCl Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, 360 mg, 420 mgNesher Pharmaceuticals (USA) LLC, 13910 St. Charles Rock Rd., Bridgeton, MO 63044.
ANDA 076699Parcopa (carbidopa and levodopa) Orally Disintegrating Tablets, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mgUCB, Inc., 1950 Lake Park Dr., Bldg. 2100, Smyrna, GA 30080.
ANDA 077275Didanosine Tablets for Oral Suspension USP, 100 mg, 150 mg, and 200 mgAurobindo Pharma Limited.
ANDA 077774Stavudine for Oral Solution USP, 1 mg/mL  Do.
ANDA 077887Carvedilol Tablets USP, 3.125 mg, 6.25 mg, 12.5 mg, 25 mgHikma Pharmaceuticals, c/o West-Ward Pharmaceuticals Corp., 401 Industrial Way West, Eatontown, NJ 07724.
ANDA 077968Alprazolam Extended-Release Tablets, 0.5 mg, 1 mg, 2 mg, and 3 mgImpax Laboratories, Inc.
ANDA 077996Alprazolam Extended-Release Tablets, 0.5 mg, 1 mg, 2 mg, 3 mg  Do.
ANDA 078112Didanosine for Oral Solution USP, 10 mg/mLAurobindo Pharma Limited.
ANDA 078240Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5 mg, and 25 mgPliva Hrvatska d.o.o., Subsidiary of Teva Pharmaceutical Industries Ltd., 425 Privet Rd., Horsham, PA 19044.
ANDA 078254Atenolol Tablets USP, 25 mg, 50 mg, and 100 mgNorthstar Healthcare Holdings, c/o Quality Regulatory Consultants, 1966 Anglers Cove, Vero Beach, FL 32963.
ANDA 078285Bicalutamide Tablets USP, 50 mgRoxane Laboratories, Inc.
ANDA 078298Sumatriptan Succinate Tablets USP, EQ 25 mg base, EQ 50 mg base, EQ 100 mg baseHikma Pharmaceuticals.
ANDA 078310Lamotrigine Tablets USP, 25 mg, 100 mg, 150 mg, and 200 mgPharmascience Inc., c/o Pharmascience Laboratories Inc., 295 Firetower Rd., Tonawanda, NY 14150.
ANDA 078334Granisol (granisetron HCl Oral Solution, 2 mg base/10mLPediatRx, Inc., c/o Cardinal Health Regulatory Sciences, 7400 West 110th St., Commerce Plaza II, Suite 300, Overland Park, KS 66210.
ANDA 078374Metoclopramide Tablets USP, EQ 5 mg base and EQ 10 mg baseNorthstar Healthcare Holdings.
ANDA 078408Vinorelbine Injection USP, EQ 10 mg base/mLSandoz Inc.
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ANDA 078501Dronabinol Capsules USP, 2.5 mg, 5 mg, and 10 mgInsys Therapeutics, Inc., 1333 South Spectrum Blvd., Suite 100, Chandler, AZ 85286.
ANDA 078577Levofloxacin Injection, EQ 750 mg/30 mL and EQ 500 mg/20 mLHospira Inc.
ANDA 078782Gabapentin Tablets USP, 600 mg and 800 mgHikma Pharmaceuticals.
ANDA 078808Granisetron HCl Injection USP, EQ 0.1 mg base/mLSandoz Inc.
ANDA 078812Oxaliplatin Injection USP, 50 mg/10 mL and 100 mg/20 mL  Do.
ANDA 078952Glimepiride Tablets USP, 1 mg, 2 mg, and 4 mgHikma Pharmaceuticals.
ANDA 079033Fomepizole Injection, 1.5 g/1.5 mLMylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103.
ANDA 080020Isopto Cetamide (sulfacetamide sodium) Ophthalmic Solution, 15%Alcon Laboratories, Inc.
ANDA 080021Sulfacetamide Sodium Ophthalmic Ointment, 10%  Do.
ANDA 080229Naphcon Forte (naphazoline HCl) Ophthalmic Solution USP 0.1%  Do.
ANDA 080248Albalon (naphazoline HCl) Ophthalmic Solution USP, 0.1%Allergan, Inc.
ANDA 080472Hytone (hydrocortisone) Cream, 1% and 2.5%Valeant International (Barbados) SRL, c/o Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
ANDA 080473Hytone (hydrocortisone) Lotion, 1% and 2.5%  Do.
ANDA 081043Prednisolone Sodium Phosphate Ophthalmic Solution USP, EQ 0.11% phosphateAlcon Pharmaceuticals, Ltd.
ANDA 081044Prednisolone Sodium Phosphate Ophthalmic Solution USP, EQ 0.9% phosphate  Do.
ANDA 083205Orabase HCA (hydrocortisone acetate) Topical Paste, 0.5%Colgate-Palmolive Co., 909 River Rd., P.O. Box 1343, Piscataway, NJ 08855-1343.
ANDA 083342Maxidex (dexamethasone sodium phosphate) Ophthalmic Ointment, EQ 0.05% phosphateAlcon Laboratories, Inc.
ANDA 084645Chlordiazepoxide HCl Capsules USP, 25 mgUpsher-Smith Laboratories, Inc.
ANDA 084927Methocarbamol Tablets USP, 500 mgImpax Laboratories, Inc.
ANDA 084928Methocarbamol Tablets USP, 750 mg  Do.
ANDA 085000Chlordiazepoxide HCl Capsules USP, 10 mgHikma Pharmaceuticals.
ANDA 085014Chlordiazepoxide HCl Capsules USP, 5 mg  Do.
ANDA 085095Statobex-G (phendimetrazine tartrate) Tablets, 35 mgTeva Pharmaceuticals USA, Inc.
ANDA 085294Chlordiazepoxide HCl Capsules USP, 25 mgHikma Pharmaceuticals.
ANDA 085380Butisol Sodium (butabarbital sodium) Oral Solution USP, 30 mg/5 mLMeda Pharmaceuticals Inc., 265 Davidson Ave., Suite #4300, Somerset, NJ 08873.
ANDA 085734Ammonium Chloride Injection USP, 40 mEQ/100 mLB. Braun Medical Inc.
ANDA 085981Hydrocortisone Acetate USP Micronized for Prescription Compounding, 100%X-Gen Pharmaceuticals, Inc.
ANDA 085982Hydro-Rx (hydrocortisone) USP Micronized for Prescription Compounding, 100%  Do.
ANDA 085995Pediatric LTA Kit (lidocaine HCl) Topical Solution USP, 2%Hospira, Inc.
ANDA 086535Acticort (hydrocortisone) Lotion USP, 1%Baker Norton Pharmaceuticals Inc., 8800 N.W. 36 St., Miami, FL 33178-2404.
ANDA 086911Phentermine HCl Capsules USP, 30 mgTeva Pharmaceuticals USA, Inc.
ANDA 087547Isopto Cetapred (sulfacetamide sodium and prednisolone acetate) Ophthalmic Ointment USP, 10%/0.25%Alcon Laboratories, Inc.
ANDA 087771Cetapred (sulfacetamide sodium and prednisolone acetate) Ophthalmic Ointment USP, 10%/0.25%  Do.
ANDA 087907Epinephrine Inhalation Aerosol USP, 0.2 mg/inhalation)Armstrong Pharmaceuticals, Inc., 25 John Rd., Canton MA 02021.
ANDA 088613Phentermine HCl Capsules USP, 30 mgTeva Pharmaceuticals USA, Inc.
ANDA 088614Phentermine HCl Capsules USP, 30 mg  Do.
ANDA 088630Pseudoephedrine HCl and Triprolidine HCl Tablets, 60 mg/2.5 mg  Do.
ANDA 088631Butabarbital Sodium Tablets, 30 mg  Do.
ANDA 088632Butabarbital Sodium Tablets, 15 mg  Do.
ANDA 088797Phentermine HCl Capsules USP, 30 mgUSL Pharma Inc., 301 South Cherokee St., Denver, CO 80223
ANDA 088910Phentermine HCl Tablets USP, 37.5 mg  Do.
ANDA 088917Phentermine HCl Tablets USP, 37.5  Do.
ANDA 088999Dipyridamole Tablets USP, 25 mgGlenmark Generics Limited, c/o Glenmark Generics Inc., USA, 750 Corporate Dr., Mahwah, NJ 07430.
ANDA 089000Dipyridamole Tablets USP, 50 mg  Do.
ANDA 089001Dipyridamole Tablets USP, 75 mg  Do.
ANDA 089068Sulfacetamide Sodium Ophthalmic Solution, 30%Alcon Pharmaceuticals, Ltd.
ANDA 089172Tropicamide Ophthalmic Solution, 1%  Do.
ANDA 089422Imipramine HCl Tablets USP, 10 mgPar Pharmaceutical Inc., One Ram Ridge Rd., Spring Valley, NY 10977.
ANDA 089440Hydrocortisone Acetate and Pramoxine HCl Topical Aerosol, 1%/1%Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL 35811.
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ANDA 089497Imipramine HCl Tablets USP, 25 mgPar Pharmaceutical Inc.
ANDA 089628Leucovorin Calcium for Injection, EQ 50 mg base/vialPharmachemie USA Inc., 323 Davis St., Northborough, MA 01532.
ANDA 089681Bromfed-DM (brompheniramine maleate, dextromethorphan hydrobromide, and pseudoephedrine HCl) Syrup, 2 mg/5 mL; 10mg/5 mL; 30mg/5 mLWockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc., 6451 Main St., Morton Grove, IL 60053.
ANDA 089915Leucovorin Calcium for Injection, EQ 100 mg base/vialPharmachemie USA Inc.
ANDA 090098Tretinoin Cream USP, 0.0375%Allergan Sales, LLC.
ANDA 090137Irinotecan HCl Injection, 40 mg/2 mL and 100 mg/5 mLSandoz Inc.
ANDA 090190Pramipexole Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg  Do.
ANDA 090220Adenosine Injection USP, 3 mg/mLWockhardt Limited, c/o Wockhardt USA LLC, 20 Waterview Blvd., 3rd Floor, Parsippany, NJ 07054.
ANDA 090300Children's Cetirizine HCl Allergy and Hives Relief Oral Solution OTC, 5 mg/5 mLCypress Pharmaceutical, Inc., 10 North Park Place, Suite 210, Morristown, NJ 07960.
ANDA 090751Cetirizine HCl Oral Solution USP, 5 mg/5 mLAurobindo Pharma Limited.
ANDA 090985Octreotide Acetate Preservative Free Injection EQ 0.05 mg base/mL, EQ 0.1 mg base/mL, and EQ 0.5 mg base/mLWockhardt Limited.
ANDA 090986Octreotide Acetate Injection EQ 0.2 mg base/mL and EQ 1 mg base/mL  Do.
ANDA 091068Ceftriaxone for Injection USP, EQ 10 g base/vialAgila Specialties Private Limited, c/o Agila Specialties Inc., 201 South Main St., Suite 3, Lambertville, NJ 08530.
ANDA 091185Topiramate Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mgHikma Pharmaceuticals.
ANDA 091293Idarubicin HCl Injection, 1 mg/mLSandoz Inc.
ANDA 091299Fluorouracil Injection USP, 2.5 g/50 mL and 5 g/100 mL  Do.
NDA 200045Amturnide (aliskiren hemifumarate, amlodipine, andhydrochlorothiazide) TabletsNovartis Pharmaceuticals Corp.
ANDA 200146Doxorubicin HCl Injection USP, 2 mg/mLSandoz Inc.
NDA 200199Topotecan Injection, EQ 1 mg base/mL, EQ 3 mg base/3 mL, and EQ 4 mg base/4 mL  Do.
ANDA 201211Bromfenac Sodium Ophthalmic Solution, EQ 0.09% acidCoastal Pharmaceuticals, 1240 Sugg Parkway, Greenville, NC 27834.
NDA 201917Incivek (telaprevir) Tablets, 375 mgVertex Pharmaceuticals, Inc., 50 Northern Ave., Boston, MA 02210.
NDA 202088Suprenza (phentermine HCl) Orally Disintegrating Tablets, 15 mg, 30 mg, and 37.5 mgCitius Pharmaceuticals, LLC, 11 Commerce Dr., First Floor, Cranford, NJ 07016.
ANDA 202209Tretinoin Cream USP, 0.075%Allergan Sales, LLC.
NDA 202513Gelnique (oxybutynin) Gel, 3%  Do.
NDA 203595Suclear (magnesium sufate, polyethylene glycol 3350, potassium chloride, potassium sulfate, sodium bicarbonate, sodium chloride, and sodium sulfate) Oral SolutionBraintree Laboratories, Inc.
NDA 204508Clinolipid 20% (olive oil and soybean oil) USP, 16%/4%Baxter Healthcare Corp.
NDA 206510Dutrebis (lamivudine and raltegravir potassium) Tablets, 150 mg/EQ 300 mg baseMerck Sharp & Dohme Corp.

Therefore, under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic 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.

Start Signature

Dated: June 15, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.

End Signature End Supplemental Information

[FR Doc. 2017-12908 Filed 6-20-17; 8:45 am]