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Notice

Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications

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Start Preamble Start Printed Page 68427

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of 44 new drug applications (NDAs) and 158 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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: November 3, 2016.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

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.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

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
NDA 005264Heparin Sodium InjectionHospira, Inc., 275 North Field Dr., Bldg. H2-2, Lake Forest, IL 60045-5046.
NDA 009470Xylocaine Viscous (lidocaine hydrochloride (HCl)) SolutionFresenius Kabi USA LLC, Three Corporate Dr., Lake Zurich, IL 60047.
NDA 009698Miltown (meprobamate) Tablets, 200 milligrams (mg) and 400 mgMeda Pharmaceuticals, Inc., 265 Davidson Ave., Suite 300, Somerset, NJ 08873-4120.
NDA 009939Senokot Granules (sennosides), 15 mgPurdue Products, L.P., One Stamford Forum, Stamford, CT 06901.
NDA 010382Tempra (acetaminophen) Syrup, 160 mg/5 milliliters (mL)Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 88543-4000.
NDA 011228Liquamar (phenprocoumon) TabletsOrganon USA Inc., Subsidiary of Merck & Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.
NDA 011613Ionamin (phentermine resin complex) Capsules, 15 mg and 30 mgUCB, Inc., 1950 Lake Park Dr., Smyrna, GA 30080.
NDA 011738Numorphan (oxymorphone HCl) Suppositories, 5 mgEndo Pharmaceuticals, Inc., 100 Endo Blvd., Chadds Ford, PA 19317.
NDA 012365Soma Compound (carisoprodol and aspirin) TabletsMeda Pharmaceuticals, Inc.
NDA 012940Isordil (isosorbide dinitrate) Sublingual Tablets, 2.5 mg, 5 mg, and 10 mgValeant International Bermuda, c/o Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
NDA 013483Drixoral/Disophrol (dexbrompheniramine maleate and pseudoephedrine sulfate) Extended-Release Tablets, 6 mg/120 mgMerck Consumer Care, 556 Morris, Ave., Summit, NJ 07901.
NDA 014005Maxibolin (ethylestrenol) TabletsOrganon USA Inc.
NDA 017087Ethrane (enflurane USP)Baxter Healthcare Corp., 32650 N. Wilson Rd., Round Lake, IL 60073.
NDA 017689Methadone HCl SyrupSandoz, Inc., 4700 Sandoz, Dr., Wilson, NC 27893.
NDA 018766Ansaid (flurbiprofen) Tablets, 50 mg and 100 mgPharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42nd St., New York, NY 10017.
NDA 018812Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/5 mL and 40 mg/5 mLTeva Pharmaceuticals USA, Inc., 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454.
NDA 019304Tricor (fenofibrate) Micronized Capsules, 67 mg, 134 mg, and 200 mgAbbVie Inc., 1 N. Waukegan Rd., Dept. PA77/Bldg. AP30, North Chicago, IL 60064.
NDA 019384Noroxin (norfloxacin) Tablets, 400 mgMerck Sharp & Dohme Corp., 351 North Sumneytown Pike, P.O. Box 1000, North Wales, PA 19454.
NDA 020005Cardene SR (nicardipine HCl) Extended-Release Capsules, 30 mg, 45 mg, and 60 mgChiesi USA, Inc., 1255 Crescent Green Dr., Suite 250, Cary, NC 27518.
NDA 020073Romazicon (flumazenil) InjectionHoffman-LaRoche, Inc., c/o Genetech, Inc., 1 DNA Way MS #241B, South San Francisco, CA 94080-4900.
NDA 020084Iobenguane Sulfate I-131 Injection, 2.3 millicuriesPharmalucence, 10 DeAngelo Dr., Bedford, MA 01730.
NDA 020107Novamine (amino acids) InjectionBaxter Healthcare Corp.
NDA 020229Leustatin (cladribine) Injection, 1 mg/mLJanssen Pharmaceuticals Inc., 920 Route 202 South, P.O. Box 300, Raritan, NJ 08869-0602.
NDA 020251Zantac (ranitidine HCl) Effervescent Tablets, 25 mg and 150 mg Zantac (ranitidine HCl) Effervescent Granules, 150 mgGlaxo Group Limited, England d/b/a GlaxoSmithKline, Five Moore Dr., P.O. Box 13398, Research Triangle Park, NC 27709.
NDA 020312Univasc (moexipril HCl) Tablets, 7.5 mg and 15 mgUCB, Inc.
NDA 020346Zyrtec (cetirizine HCl) Syrup, 1 mg/mLJohnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division, 7050 Camp Hill Rd., Fort Washington, PA 19034-2299.
NDA 020410Gastromark (ferumoxsil) Oral SuspensionAMAG Pharmaceuticals, 100 Haydon Ave., Lexington, MA 02421.
Start Printed Page 68428
NDA 020416Feridex I.V. (ferumoxides) InjectionDo.
NDA 020460Cytovene (ganciclovir) Capsules, 250 mg and 500 mgRoche Palo Alto LLC, c/o Genentech, Inc., 1 DNA Way, MS#241B, South San Francisco, CA 94080-4990.
NDA 020575DentiPatch (lidocaine)Noven Pharmaceuticals, Inc., 11960 SW. 144th St., Miami, FL 33186.
NDA 020638Vistide (cidofovir) Injection, Equivalent to (EQ) 75 mg base/mLGilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404.
NDA 020729Uniretic (moexipril HCl and hydrochlorothiazide) Tablets, 7.5 mg/12.5 mg, 15 mg/12.5 mg, and 15 mg/25 mgUCB, Inc.
NDA 021044Palladone (hydromorphone HCl) Extended-Release CapsulesRhodes Pharmaceuticals L.P., 498 Washington St., Coventry, RI 02816.
NDA 021046Celexa (citalopram hydrobromide) EQ 10 mg base/5 mL Oral SolutionForest Laboratories, Inc., Harborside Financial Center, Plaza V, Suite 1900, Jersey, City, NJ 07311.
NDA 021378Combunox (Oxycodone HCl and Ibuprofen) TabletsDo.
NDA 021671DepoDur (morphine sulfate) Extended-Release InjectionPacira Pharmaceuticals, Inc., 10450 Science Center Dr., San Diego, CA 92121.
NDA 021693Rybix ODT (tramadol HCl) Orally Disintegrating TabletsShionogi, Inc., 300 Campus Dr., Suite 300, Florham Park, NJ 07932.
NDA 021768Fludeoxyglucose F18 (FDG) InjectionWeill Medical College of Cornell University, c/o Citigroup Biomedical Imaging Center, 516 East 72nd St., New York, NY 10021.
NDA 022244Lusedra (fospropofol disodium) InjectionEisai, Inc., 155 Tice Blvd., Woodcliff Lake, NJ 07677.
NDA 022312Docetaxel InjectionApotex Inc., c/o Apotex Corp., 2400 North Commerce Parkway, Suite 400, Weston, FL 33326.
ANDA 040223Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg, 300 mg/30 mg, and 300 mg/60 mgBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 040297Estradiol Tablets USP, 0.5 mg, 1 mg, and 2 mgUpsher-Smith Laboratories, Inc., 6701 Evenstad Dr., Maple Grove, MN 55369.
ANDA 040311Medroxyprogesterone Acetate Tablets USP, 2.5 mg, 5 mg, and 10 mgDuramed Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 040318Meperidine HCl Tablets USP, 50 mg and 100 mgDo.
ANDA 040472Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TabletsTeva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
NDA 050143Chloromycetin (chloramphenicol ophthalmic solution USP) Ophthalmic SolutionParkedale Pharmaceuticals, Inc., c/o King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620.
NDA 050156Chloromycetin (chloramphenicol ophthalmic ointment USP) Ophthalmic Ointment, 1%Do.
NDA 050443Blenoxane (bleomycin sulfate) for Injection, EQ 15 units base/vial and 30 units base/vialBristol-Myers Squibb Co.
NDA 050630Primaxin (imipenem and cilastatin sodium) Powder, EQ 500 mg base/vial; 500 mg/vial and EQ 750 mg base/vial; 750 mg/vialMerck, Sharp & Dohme Corp.
ANDA 060306Penicillin G Potassium Tablets USPTeva Pharmaceuticals USA, Inc.
ANDA 060307Penicillin G Potassium for Oral Solution USPDo.
ANDA 061969Cephalexin Capsules USP, EQ 250 mg base and EQ 500 mg baseIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 062240Cloxacillin Sodium Capsules USP, EQ 250 mg base and EQ 500 mg baseTeva Pharmaceuticals USA, Inc.
ANDA 062252Oxacillin Sodium for Oral Solution USP, EQ 250 mg base/5 mLTeva Pharmaceuticals USA, Inc.
ANDA 062268Cloxacillin Sodium for Oral Solution USP, EQ 125 mg base/5 mLDo.
ANDA 062653Doryx (doxycycline hyclate) Delayed-Release Capsules, EQ 100 mg baseWarner Chilcott Co., LLC, c/o Warner Chilcott (US), LLC, 100 Enterprise Dr., Rockaway, NJ 07866.
ANDA 062670Nystatin Oral Suspension USP, 100,000 units/mLTeva Pharmaceuticals USA, Inc.
ANDA 062683Cephradine Capsules USP, 250 mg and 500 mgDo.
ANDA 062695Cefadroxil Capsules USP, EQ 500 mg baseDo.
ANDA 062751Erythromycin Pledgets USP, 2%Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 062760Cephalexin Capsules USP, EQ 250 mg baseTeva Pharmaceuticals USA, Inc.
ANDA 062761Cephalexin Capsules USP, EQ 500 mg baseDo.
ANDA 062766Cefadroxil Capsules USP, EQ 500 mg baseIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 062767Cephalexin for Oral Suspension USP, EQ 125 mg base/5 mLTeva Pharmaceuticals USA, Inc.
ANDA 062768Cephalexin for Oral Suspension USP, EQ 250 mg base/5 mLDo.
ANDA 062775Cephalexin Capsules USP, EQ 500 mg baseBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 062853Amoxicillin Capsules USP, 250 mgTeva Pharmaceuticals USA, Inc.
ANDA 062854Amoxicillin Capsules USP, 500 mgDo.
ANDA 062946Amoxicillin for Oral Suspension USP, 125 mg/5 mLDo.
ANDA 063001Amoxicillin for Oral Suspension USP, 250 mg/5 mLDo.
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ANDA 063018Cefazolin Sodium for Injection USP, EQ 5 grams (g) base/vial and EQ 10 g base/vialDo.
ANDA 063027Clindamycin HCl Capsules USP, EQ 75 mg baseDo.
ANDA 063030Amoxicillin Capsules USP, 250 mgDo.
ANDA 063031Amoxicillin Capsules USP, 500 mgDo.
ANDA 064031Amoxicillin Chewable Tablets, 125 mg and 250 mgDo.
ANDA 064081Cefaclor Capsules USP, EQ 250 mg base and EQ 500 mg baseDo.
ANDA 064145Cefaclor Capsules USP, EQ 250 mg base and EQ 500 mg baseDo.
ANDA 065137Clarithromycin Tablets USP, 250 mg and 500 mgIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 070006Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/80 mgMutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124.
ANDA 070007Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mgDo.
ANDA 070232Propranolol HCl Tablets USP, 10 mgTeva Pharmaceuticals USA, Inc.
ANDA 070234Propranolol HCl Tablets USP, 40 mgDo.
ANDA 070266Indo-Lemmon (Indomethacin Capsules USP), 25 mgDo.
ANDA 070267Indo-Lemmon (Indomethacin Capsules USP), 50 mgDo.
ANDA 070469Ibuprohn (Ibuprofen Tablets USP), 400 mgOhm Laboratories, Inc., c/o Ranbaxy Inc., 600 College Rd. East, Princeton, NJ 08540.
ANDA 070618Potassium Chloride Extended-Release Tablets USP, 8 milliequivalentsCopley Pharmaceutical, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 070660Metoclopramide HCl Tablets USP, EQ 10 mg baseMutual Pharmaceutical Co., Inc.
ANDA 071145Ibuprofen Tablets USPIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 071146Ibuprofen Tablets USP, 600 mgDo.
ANDA 071184Thiothixene HCl Oral Solution USP, EQ 5 mg base/mLTeva Pharmaceuticals USA, Inc.
ANDA 071342Indomethacin Capsules USP, 25 mgDo.
ANDA 071343Indomethacin Capsules USP, 50 mgDo.
ANDA 072438Fenoprofen Calcium Capsules USP, EQ 300 mg basePar Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977.
ANDA 072522Fluocinonide Topical Solution USP, 0.05%Teva Pharmaceuticals USA, Inc.
ANDA 072600Clofibrate Capsules USP, 500 mgDo.
ANDA 072692Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mgBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals, USA, Inc.
ANDA 072999Dopamine HCl Injection USP, 200 mg/5 mLTeva Parenteral Medicines, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 073005Cinoxacin Capsules USP, 250 mgTeva Pharmaceuticals USA, Inc.
ANDA 073006Cinoxacin Capsules USP, 500 mgDo.
ANDA 073043Baclofen Tablets USP, 10 mgDo.
ANDA 073044Baclofen Tablets USP, 20 mgDo.
ANDA 073099Leucovorin Calcium Tablets USP, EQ 5 mg basePharmachemie B.V., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 073101Leucovorin Calcium Tablets USP, EQ 25 mg baseDo.
ANDA 073141Ibuprofen Tablets USP, 200 mgTeva Pharmaceuticals USA, Inc.
ANDA 073315Atenolol Tablets USP, 50 mgDo.
ANDA 073316Atenolol Tablets USP, 100 mgDo.
ANDA 073343Ibuprofen Tablets USP, 400 mgDo.
ANDA 073344Ibuprofen Tablets USP, 600 mgDo.
ANDA 073345Ibuprofen Tablets USP, 800 mgDo.
ANDA 073515Ketoprofen Capsules USP, 25 mgDo.
ANDA 073679Diflunisal Tablets USP, 250 mgDo.
ANDA 074067Diltiazem HCl Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mgDo.
ANDA 074107Atenolol and Chlorthalidone Tablets USP, 50 mg/25 mg and 100 mg/25 mgPliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 074120Atenolol Tablets USP, 50 mg and 100 mgTeva Pharmaceuticals USA, Inc.
ANDA 074123Pindolol Tablets USP, 5 mg and 10 mgG&W Laboratories, Inc., 111 Coolidge St., South Plainfield, NJ 07080.
ANDA 074124Ciprofloxacin HCl Tablets, EQ 250 mg base, EQ 500 mg base, and EQ 750 mg baseBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 074143Metoprolol Tartrate Tablets USP, 50 mg and 100 mgTeva Pharmaceuticals USA, Inc.
ANDA 074216Naproxen Tablets, 250 mg, 375 mg, and 500 mgDo.
ANDA 074294Alprazolam Tablets USP, 0.25 mg, 0.5 mg, 1 mg, and 2 mgIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 074333Metoprolol Tartrate Tablets USP, 50 mg and 100 mgTeva Pharmaceuticals USA, Inc.
ANDA 074357Trazodone HCl Tablets USP, 150 mgDo.
ANDA 074365Cimetidine Tablets USP, 200 mg, 300 mg, 400 mg, and 800 mgDo.
Start Printed Page 68430
ANDA 074446Terazosin HCl Tablets, EQ 1 mg base, EQ 2 mg base, EQ 5 mg base, and EQ 10 mg baseDo.
ANDA 074459Diclofenac Sodium Delayed-Release Tablets USP, 25 mg, 50 mg, and 75 mgDo.
ANDA 074476Hydroxyurea Capsules USP, 500 mgRoxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228.
ANDA 074504Tamoxifen Citrate Tablets USP, EQ 10 mg base and EQ 20 mg baseTeva Pharmaceuticals USA, Inc.
ANDA 074537Selegiline HCl Tablets USP, 5 mgG&W Laboratories, Inc.
ANDA 074555Cholestyramine for Oral Suspension USPTeva Pharmaceuticals, USA, Inc.
ANDA 074674Acyclovir Capsules USP, 200 mgIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 074745Megestrol Acetate Tablets USP, 40 mgTeva Pharmaceuticals USA, Inc.
ANDA 074771Cholestyramine for Oral Suspension USPDo.
ANDA 074847Etodolac Tablets USP, 400 mg and 500 mgDo.
ANDA 074883Etodolac Tablets USP, 400 mg and 500 mgIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 074895Amiodarone HCl Tablets, 200 mgTeva Pharmaceuticals USA, Inc.
ANDA 074914Acyclovir Capsules USP, 200 mgDo.
ANDA 074989Labetalol HCl Tablets USP, 100 mg, 200 mg, and 300 mgDo.
ANDA 075021Acyclovir Tablets USP, 400 mg and 800 mgDo.
ANDA 075557Ranitidine HCl Capsules, EQ 150 mg base and EQ 300 mg baseDo.
ANDA 075686Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mgDo.
ANDA 075719Sertraline HCl Tablets USP, EQ 25 mg base, EQ 50 mg base, and EQ 100 mg baseDo.
ANDA 075726Pemoline Tablets, 18.75 mg, 37.5 mg, and 75 mgMallinckrodt Inc., 675 McConnell Blvd., Hazelwood, MO 63042.
ANDA 075740Tamoxifen Citrate Tablets USP, EQ 10 mg base and EQ 20 mg baseIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 075810Fluoxetine HCl Tablets , EQ 10 mg baseBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 075823Calcitriol Injection USP, 0.001 mg/mL and 0.002 mg/mLTeva Parenteral Medicines, Inc.
ANDA 075827Gabapentin Tablets USP, 600 mg and 800 mgTeva Pharmaceuticals USA, Inc.
ANDA 075862Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/0.02 mgBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 075865Fluoxetine HCl Tablets , EQ 10 mg base and EQ 40 mg baseIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 075971Metformin HCl Tablets USP, 500 mg, 850 mg, and 1 gBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 075975Metformin HCl Tablets USP, 500 mg, 625 mg, 750 mg, 850 mg, and 1 gIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 076094Pergolide Mesylate Tablets, EQ 0.05 mg base, EQ 0.25 mg base, and EQ 1 mg baseDo.
ANDA 076184Alendronate Sodium Tablets USP, EQ 35 mg tablets and EQ 70 mg tabletsTeva Pharmaceuticals USA, Inc.
ANDA 076198Balziva-21 Tablets (norethindrone and ethinyl estradiol tablets USP), 0.4 mg/0.035 mgBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 076244Mirtazapine Tablets USP, 15 mg, 30 mg, and 45 mgIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 076251Fluoxetine HCl Capsules, EQ 40 mg baseBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 076328Metformin HCl Tablets USP, 500 mg, 850 mg, and 1 gTeva Pharmaceuticals USA, Inc.
ANDA 076340Finasteride Tablets USP, 5 mgIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 076426Ciprofloxacin HCl Tablets , EQ 100 mg base, EQ 250 mg base, EQ 500 mg base, and EQ 750 mg basePliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 076496Metformin HCl Extended-Release Tablets USP, 500 mgBarr Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 076545Metformin HCl Extended-Release Tablets USP, 500 mgIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 076840Sumatriptan Succinate Tablets, EQ 25 mg base, EQ 50 mg base, and EQ 100 mg baseTeva Pharmaceuticals USA, Inc.
ANDA 076880Nicotine Polacrilex Gum USP, EQ 2 mg baseIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 076945Fosinopril Sodium and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg and 20 mg/12.5 mgTeva Pharmaceuticals USA, Inc.
ANDA 077020Cilostazol Tablets USP, 100 mgIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 077082Paroxetine Tablets USP, EQ 10 mg base, EQ 20 mg base, EQ 30 mg base, and EQ 40 mg baseTeva Pharmaceuticals USA, Inc.
Start Printed Page 68431
ANDA 077775Fentanyl Extended-Release Film, 25 micrograms (mcg), 50 mcg, 75 mcg, and 100 mcgNoven, Pharmaceuticals, Inc.
ANDA 077850Nicotine Polacrilex Gum USP, EQ 4 mg baseIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 077898Cilostazol Tablets USP, 50 mg and 100 mgPliva Hrvatska DOO, c/o Teva Pharmaceuticals USA, Inc.,425 Privet Rd., Horsham, PA 19044.
ANDA 077973Bicalutamide Tablets USP, 50 mgSynthon Pharmaceuticals, Inc., 9000 Development Dr., P.O. Box 110487, Research Triangle Park, NC 27709.
ANDA 077995Bicalutamide Tablets UPS, 50 mgKudco Ireland Limited, c/o Kremers Urban Pharmaceuticals, Inc., 1101 C Ave. West, Seymour, IN 47274.
ANDA 078079Ciclopirox Topical Solution USP, 8%Teva Pharmaceuticals USA, Inc.
ANDA 078221Granisetron HCl Tablets USP, EQ 1 mg baseBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 078263Perindopril Erbumine Tablets, 2 mg, 4 mg, and 8 mgLupin Limited, c/o Lupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 21st Floor, Baltimore, MD 21202.
ANDA 078567Ciclopirox Topical Solution USP, 8%Mylan Pharmaceuticals Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504.
ANDA 078666Levonorgestrel Tablets, 0.75 mgWatson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880.
ANDA 078773Atorvastatin Calcium Tablets, EQ 10 mg base, EQ 20 mg (base), EQ 40 mg base, and EQ 80 mg baseTeva Pharmaceuticals USA, Inc.
ANDA 080400Hydrocortisone Cream USPDo.
ANDA 080828Hydrocortisone Acetate Ophthalmic Ointment USP, 0.5%Fera Pharmaceuticals LLC, 134 Birch Hill Rd., Locust Valley, NY 11560.
ANDA 083919Meprobamate Tablets USP, 600 mgMeda Pharmaceuticals Inc., 265 Davidson Ave., Suite 400, Somerset, NJ 08873.
ANDA 085022Hydrochlorothiazide Tablets USP, 100 mgIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 085855A-Methapred (methylprednisolone sodium succinate for Injection USP), EQ 125 mg base/vialHospira, Inc.
ANDA 086750Ergotamine Tartrate Sublingual Tablets USP, 2 mgOrganon USA, Inc.
ANDA 087014Orgatrax (hydroxyzine HCl Injection USP), 25 mg/mL and 50 mg/mLDo.
ANDA 087264Thioridazine HCl Tablets USP, 25 mgMutual Pharmaceutical Co., Inc.
ANDA 087665Sulfinpyrazone Tablets USP, 100 mgBarr Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 087666Sulfinpyrazone Capsules USP, 200 mgDo.
ANDA 087760Hydroxyzine Pamoate Capsules USP, EQ 50 mg HClIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 087761Hydroxyzine Pamoate Capsules USP, EQ 25 mg HClDo.
ANDA 088370Thioridazine HCl Tablets USP, 50 mgMutual Pharmaceutical Co., Inc.
ANDA 088375Thioridazine HCl Tablets USP, 10 mgDo.
ANDA 088379Thioridazine HCl Tablets USP, 100 mgDo.
ANDA 088469Dexamethasone Sodium Phosphate Injection USP, EQ 10 mg Phosphate/mLFresenius Kabi USA, LLC.
ANDA 088900Doxylamine Succinate Tablets USP, 25 mgCopley Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 088902Chlorthalidone Tablets USP, 25 mgBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 088903Chlorthalidone Tablets USP, 50 mgDo.
ANDA 088974Procainamide HCl Extended-Release Tablets USP, 500 mgANI Pharmaceuticals, Inc.,.
ANDA 089109Promethazine HCl Tablets USP, 25 mgTeva Pharmaceuticals USA, Inc.
ANDA 090299Melphalan HCl for Injection, EQ 50 mg base/vialMylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103.
ANDA 090924Ibutilide Fumarate Injection, 0.1 mg/mLDo.
ANDA 091242Anastrozole Tablets USP, 1 mgImpax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544.
ANDA 091638Letrozole Tablets USP, 2.5 mgDo.
ANDA 200792Oxymorphone HCl Extended-Release Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mgPar Pharmaceutical, Inc.
ANDA 204538Zidovudine Injection USP, 10 mg/mLLiaoning Chengda Biotechnology Co., Ltd., c/o Ruby Pharma, Inc., 116 Village Blvd, Suite 200, Princeton, NJ 08540.

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 November 3, 2016. Introduction or delivery for introduction into interstate Start Printed Page 68432commerce 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.

Start Signature

Dated: September 27, 2016.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2016-23893 Filed 10-3-16; 8:45 am]

BILLING CODE 4164-01-P