Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications, 68427-68432 [2016-23893]

Download as PDF Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0002] Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing SUMMARY: 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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. 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, 68427 Silver Spring, MD 20993–0002, 301– 796–3601. 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. SUPPLEMENTARY INFORMATION: TABLE 1 Application No. Drug Applicant NDA 005264 ...... Heparin Sodium Injection ......................................................... NDA 009470 ...... Xylocaine Viscous (lidocaine hydrochloride (HCl)) Solution .... NDA 009698 ...... NDA 009939 ...... Miltown (meprobamate) Tablets, 200 milligrams (mg) and 400 mg. Senokot Granules (sennosides), 15 mg .................................. NDA 010382 ...... Tempra (acetaminophen) Syrup, 160 mg/5 milliliters (mL) ..... NDA 011228 ...... Liquamar (phenprocoumon) Tablets ........................................ NDA 011613 ...... Ionamin (phentermine resin complex) Capsules, 15 mg and 30 mg. Numorphan (oxymorphone HCl) Suppositories, 5 mg ............. Hospira, Inc., 275 North Field Dr., Bldg. H2–2, Lake Forest, IL 60045–5046. Fresenius Kabi USA LLC, Three Corporate Dr., Lake Zurich, IL 60047. Meda Pharmaceuticals, Inc., 265 Davidson Ave., Suite 300, Somerset, NJ 08873–4120. Purdue Products, L.P., One Stamford Forum, Stamford, CT 06901. Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 88543–4000. Organon USA Inc., Subsidiary of Merck & Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033. UCB, Inc., 1950 Lake Park Dr., Smyrna, GA 30080. NDA 011738 ...... NDA 012365 ...... NDA 012940 ...... Soma Compound (carisoprodol and aspirin) Tablets .............. Isordil (isosorbide dinitrate) Sublingual Tablets, 2.5 mg, 5 mg, and 10 mg. NDA 013483 ...... NDA 014005 ...... NDA 017087 ...... Drixoral/Disophrol (dexbrompheniramine maleate and pseudoephedrine sulfate) Extended-Release Tablets, 6 mg/120 mg. Maxibolin (ethylestrenol) Tablets ............................................. Ethrane (enflurane USP) .......................................................... NDA 017689 ...... NDA 018766 ...... Methadone HCl Syrup .............................................................. Ansaid (flurbiprofen) Tablets, 50 mg and 100 mg ................... NDA 018812 ...... Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/5 mL and 40 mg/5 mL. Tricor (fenofibrate) Micronized Capsules, 67 mg, 134 mg, and 200 mg. Noroxin (norfloxacin) Tablets, 400 mg ..................................... NDA 019304 ...... NDA 019384 ...... NDA 020073 ...... Cardene SR (nicardipine HCl) Extended-Release Capsules, 30 mg, 45 mg, and 60 mg. Romazicon (flumazenil) Injection ............................................. NDA 020084 ...... NDA 020107 ...... NDA 020229 ...... mstockstill on DSK3G9T082PROD with NOTICES NDA 020005 ...... Iobenguane Sulfate I–131 Injection, 2.3 millicuries ................. Novamine (amino acids) Injection ............................................ Leustatin (cladribine) Injection, 1 mg/mL ................................. NDA 020251 ...... Zantac (ranitidine HCl) Effervescent Tablets, 25 mg and 150 mg Zantac (ranitidine HCl) Effervescent Granules, 150 mg. NDA 020312 ...... NDA 020346 ...... Univasc (moexipril HCl) Tablets, 7.5 mg and 15 mg ............... Zyrtec (cetirizine HCl) Syrup, 1 mg/mL ................................... NDA 020410 ...... Gastromark (ferumoxsil) Oral Suspension ............................... VerDate Sep<11>2014 19:01 Oct 03, 2016 Jkt 241001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Endo Pharmaceuticals, Inc., 100 Endo Blvd., Chadds Ford, PA 19317. Meda Pharmaceuticals, Inc. Valeant International Bermuda, c/o Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. Merck Consumer Care, 556 Morris, Ave., Summit, NJ 07901. Organon USA Inc. Baxter Healthcare Corp., 32650 N. Wilson Rd., Round Lake, IL 60073. Sandoz, Inc., 4700 Sandoz, Dr., Wilson, NC 27893. Pharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42nd St., New York, NY 10017. Teva Pharmaceuticals USA, Inc., 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454. AbbVie Inc., 1 N. Waukegan Rd., Dept. PA77/Bldg. AP30, North Chicago, IL 60064. Merck Sharp & Dohme Corp., 351 North Sumneytown Pike, P.O. Box 1000, North Wales, PA 19454. Chiesi USA, Inc., 1255 Crescent Green Dr., Suite 250, Cary, NC 27518. Hoffman-LaRoche, Inc., c/o Genetech, Inc., 1 DNA Way MS #241B, South San Francisco, CA 94080–4900. Pharmalucence, 10 DeAngelo Dr., Bedford, MA 01730. Baxter Healthcare Corp. Janssen Pharmaceuticals Inc., 920 Route 202 South, P.O. Box 300, Raritan, NJ 08869–0602. Glaxo Group Limited, England d/b/a GlaxoSmithKline, Five Moore Dr., P.O. Box 13398, Research Triangle Park, NC 27709. UCB, Inc. Johnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division, 7050 Camp Hill Rd., Fort Washington, PA 19034–2299. AMAG Pharmaceuticals, 100 Haydon Ave., Lexington, MA 02421. E:\FR\FM\04OCN1.SGM 04OCN1 68428 Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices TABLE 1—Continued Application No. Drug Applicant NDA 020416 ...... NDA 020460 ...... Feridex I.V. (ferumoxides) Injection ......................................... Cytovene (ganciclovir) Capsules, 250 mg and 500 mg .......... NDA 020575 ...... DentiPatch (lidocaine) .............................................................. NDA 020638 ...... Vistide (cidofovir) Injection, Equivalent to (EQ) 75 mg base/ mL. Uniretic (moexipril HCl and hydrochlorothiazide) Tablets, 7.5 mg/12.5 mg, 15 mg/12.5 mg, and 15 mg/25 mg. Palladone (hydromorphone HCl) Extended-Release Capsules Do. Roche Palo Alto LLC, c/o Genentech, Inc., 1 DNA Way, MS#241B, South San Francisco, CA 94080–4990. Noven Pharmaceuticals, Inc., 11960 SW. 144th St., Miami, FL 33186. Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404. UCB, Inc. NDA 020729 ...... NDA 021044 ...... NDA 021046 ...... NDA 021378 ...... NDA 021671 ...... Celexa (citalopram hydrobromide) EQ 10 mg base/5 mL Oral Solution. Combunox (Oxycodone HCl and Ibuprofen) Tablets .............. DepoDur (morphine sulfate) Extended-Release Injection ....... NDA 021693 ...... Rybix ODT (tramadol HCl) Orally Disintegrating Tablets ........ NDA 021768 ...... Fludeoxyglucose F18 (FDG) Injection ..................................... NDA 022244 ...... NDA 022312 ...... Lusedra (fospropofol disodium) Injection ................................. Docetaxel Injection ................................................................... ANDA 040223 .... Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg, 300 mg/30 mg, and 300 mg/60 mg. Estradiol Tablets USP, 0.5 mg, 1 mg, and 2 mg .................... ANDA 040297 .... ANDA 040311 .... .... .... .... .... Medroxyprogesterone Acetate Tablets USP, 2.5 mg, 5 mg, and 10 mg. Meperidine HCl Tablets USP, 50 mg and 100 mg .................. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets. Chloromycetin (chloramphenicol ophthalmic solution USP) Ophthalmic Solution. Chloromycetin (chloramphenicol ophthalmic ointment USP) Ophthalmic Ointment, 1%. Blenoxane (bleomycin sulfate) for Injection, EQ 15 units base/vial and 30 units base/vial. Primaxin (imipenem and cilastatin sodium) Powder, EQ 500 mg base/vial; 500 mg/vial and EQ 750 mg base/vial; 750 mg/vial. Penicillin G Potassium Tablets USP ........................................ Penicillin G Potassium for Oral Solution USP ......................... Cephalexin Capsules USP, EQ 250 mg base and EQ 500 mg base. Cloxacillin Sodium Capsules USP, EQ 250 mg base and EQ 500 mg base. Oxacillin Sodium for Oral Solution USP, EQ 250 mg base/5 mL. Cloxacillin Sodium for Oral Solution USP, EQ 125 mg base/5 mL. Doryx (doxycycline hyclate) Delayed-Release Capsules, EQ 100 mg base. Nystatin Oral Suspension USP, 100,000 units/mL .................. Cephradine Capsules USP, 250 mg and 500 mg ................... Cefadroxil Capsules USP, EQ 500 mg base ........................... Erythromycin Pledgets USP, 2% ............................................. ANDA 062760 .... ANDA 062761 .... ANDA 062766 .... Cephalexin Capsules USP, EQ 250 mg base ......................... Cephalexin Capsules USP, EQ 500 mg base ......................... Cefadroxil Capsules USP, EQ 500 mg base ........................... ANDA 062767 .... ANDA 062768 .... ANDA 062775 .... Cephalexin for Oral Suspension USP, EQ 125 mg base/5 mL Cephalexin for Oral Suspension USP, EQ 250 mg base/5 mL Cephalexin Capsules USP, EQ 500 mg base ......................... ANDA ANDA ANDA ANDA Amoxicillin Amoxicillin Amoxicillin Amoxicillin ANDA 040318 .... ANDA 040472 .... NDA 050143 ...... NDA 050156 ...... NDA 050443 ...... NDA 050630 ...... ANDA 060306 .... ANDA 060307 .... ANDA 061969 .... ANDA 062240 .... ANDA 062252 .... ANDA 062268 .... ANDA 062653 .... mstockstill on DSK3G9T082PROD with NOTICES ANDA ANDA ANDA ANDA 062670 062683 062695 062751 062853 062854 062946 063001 VerDate Sep<11>2014 .... .... .... .... 19:01 Oct 03, 2016 Capsules USP, 250 mg ......................................... Capsules USP, 500 mg ......................................... for Oral Suspension USP, 125 mg/5 mL ............... for Oral Suspension USP, 250 mg/5 mL ............... Jkt 241001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 Rhodes Pharmaceuticals L.P., 498 Washington St., Coventry, RI 02816. Forest Laboratories, Inc., Harborside Financial Center, Plaza V, Suite 1900, Jersey, City, NJ 07311. Do. Pacira Pharmaceuticals, Inc., 10450 Science Center Dr., San Diego, CA 92121. Shionogi, Inc., 300 Campus Dr., Suite 300, Florham Park, NJ 07932. Weill Medical College of Cornell University, c/o Citigroup Biomedical Imaging Center, 516 East 72nd St., New York, NY 10021. Eisai, Inc., 155 Tice Blvd., Woodcliff Lake, NJ 07677. Apotex Inc., c/o Apotex Corp., 2400 North Commerce Parkway, Suite 400, Weston, FL 33326. Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. Upsher-Smith Laboratories, Inc., 6701 Evenstad Dr., Maple Grove, MN 55369. Duramed Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA Inc., 425 Privet Rd., Horsham, PA 19044. Do. Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. Parkedale Pharmaceuticals, Inc., c/o King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620. Do. Bristol-Myers Squibb Co. Merck, Sharp & Dohme Corp. Teva Pharmaceuticals USA, Inc. Do. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Teva Pharmaceuticals USA, Inc. Teva Pharmaceuticals USA, Inc. Do. Warner Chilcott Co., LLC, c/o Warner Chilcott (US), LLC, 100 Enterprise Dr., Rockaway, NJ 07866. Teva Pharmaceuticals USA, Inc. Do. Do. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Teva Pharmaceuticals USA, Inc. Do. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Teva Pharmaceuticals USA, Inc. Do. Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Teva Pharmaceuticals USA, Inc. Do. Do. Do. E:\FR\FM\04OCN1.SGM 04OCN1 Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices 68429 TABLE 1—Continued Application No. Drug ANDA 063018 .... Cefazolin Sodium for Injection USP, EQ 5 grams (g) base/ vial and EQ 10 g base/vial. Clindamycin HCl Capsules USP, EQ 75 mg base .................. Amoxicillin Capsules USP, 250 mg ......................................... Amoxicillin Capsules USP, 500 mg ......................................... Amoxicillin Chewable Tablets, 125 mg and 250 mg ............... Cefaclor Capsules USP, EQ 250 mg base and EQ 500 mg base. Cefaclor Capsules USP, EQ 250 mg base and EQ 500 mg base. Clarithromycin Tablets USP, 250 mg and 500 mg .................. ANDA ANDA ANDA ANDA ANDA 063027 063030 063031 064031 064081 .... .... .... .... .... ANDA 064145 .... ANDA 065137 .... ANDA 070006 .... ANDA 070007 .... ANDA ANDA ANDA ANDA ANDA 070232 070234 070266 070267 070469 .... .... .... .... .... ANDA 070618 .... Applicant Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/80 mg. Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/ 160 mg. Propranolol HCl Tablets USP, 10 mg ...................................... Propranolol HCl Tablets USP, 40 mg ...................................... Indo-Lemmon (Indomethacin Capsules USP), 25 mg ............. Indo-Lemmon (Indomethacin Capsules USP), 50 mg ............. Ibuprohn (Ibuprofen Tablets USP), 400 mg ............................ ANDA 070660 .... ANDA 071145 .... Potassium Chloride Extended-Release Tablets USP, 8 milliequivalents. Metoclopramide HCl Tablets USP, EQ 10 mg base ............... Ibuprofen Tablets USP ............................................................. ANDA ANDA ANDA ANDA ANDA .... .... .... .... .... Ibuprofen Tablets USP, 600 mg .............................................. Thiothixene HCl Oral Solution USP, EQ 5 mg base/mL ......... Indomethacin Capsules USP, 25 mg ....................................... Indomethacin Capsules USP, 50 mg ....................................... Fenoprofen Calcium Capsules USP, EQ 300 mg base .......... ANDA 072522 .... ANDA 072600 .... ANDA 072692 .... ANDA 072999 .... Fluocinonide Topical Solution USP, 0.05% ............................. Clofibrate Capsules USP, 500 mg ........................................... Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/ 0.035 mg. Dopamine HCl Injection USP, 200 mg/5 mL ........................... ANDA ANDA ANDA ANDA ANDA 073005 073006 073043 073044 073099 .... .... .... .... .... Cinoxacin Capsules USP, 250 mg .......................................... Cinoxacin Capsules USP, 500 mg .......................................... Baclofen Tablets USP, 10 mg ................................................. Baclofen Tablets USP, 20 mg ................................................. Leucovorin Calcium Tablets USP, EQ 5 mg base .................. ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA 073101 073141 073315 073316 073343 073344 073345 073515 073679 074067 .... .... .... .... .... .... .... .... .... .... Leucovorin Calcium Tablets USP, EQ 25 mg base ................ Ibuprofen Tablets USP, 200 mg .............................................. Atenolol Tablets USP, 50 mg .................................................. Atenolol Tablets USP, 100 mg ................................................ Ibuprofen Tablets USP, 400 mg .............................................. Ibuprofen Tablets USP, 600 mg .............................................. Ibuprofen Tablets USP, 800 mg .............................................. Ketoprofen Capsules USP, 25 mg ........................................... Diflunisal Tablets USP, 250 mg ............................................... Diltiazem HCl Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg. Atenolol and Chlorthalidone Tablets USP, 50 mg/25 mg and 100 mg/25 mg. Atenolol Tablets USP, 50 mg and 100 mg .............................. Pindolol Tablets USP, 5 mg and 10 mg .................................. 071146 071184 071342 071343 072438 ANDA 074107 .... ANDA 074120 .... ANDA 074123 .... mstockstill on DSK3G9T082PROD with NOTICES ANDA 074124 .... ANDA 074143 .... ANDA 074216 .... ANDA 074294 .... ANDA 074333 .... ANDA 074357 .... ANDA 074365 .... VerDate Sep<11>2014 Ciprofloxacin HCl Tablets, EQ 250 mg base, EQ 500 mg base, and EQ 750 mg base. Metoprolol Tartrate Tablets USP, 50 mg and 100 mg ............ Naproxen Tablets, 250 mg, 375 mg, and 500 mg .................. Alprazolam Tablets USP, 0.25 mg, 0.5 mg, 1 mg, and 2 mg Metoprolol Tartrate Tablets USP, 50 mg and 100 mg ............ Trazodone HCl Tablets USP, 150 mg ..................................... Cimetidine Tablets USP, 200 mg, 300 mg, 400 mg, and 800 mg. 19:01 Oct 03, 2016 Jkt 241001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Do. Do. Do. Do. Do. Do. Do. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124. Do. Teva Pharmaceuticals USA, Inc. Do. Do. Do. Ohm Laboratories, Inc., c/o Ranbaxy Inc., 600 College Rd. East, Princeton, NJ 08540. Copley Pharmaceutical, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. Mutual Pharmaceutical Co., Inc. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Do. Teva Pharmaceuticals USA, Inc. Do. Do. Par Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977. Teva Pharmaceuticals USA, Inc. Do. Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals, USA, Inc. Teva Parenteral Medicines, Inc., 425 Privet Rd., Horsham, PA 19044. Teva Pharmaceuticals USA, Inc. Do. Do. Do. Pharmachemie B.V., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. Do. Teva Pharmaceuticals USA, Inc. Do. Do. Do. Do. Do. Do. Do. Do. Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. Teva Pharmaceuticals USA, Inc. G&W Laboratories, Inc., 111 Coolidge St., South Plainfield, NJ 07080. Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Teva Pharmaceuticals USA, Inc. Do. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Teva Pharmaceuticals USA, Inc. Do. Do. E:\FR\FM\04OCN1.SGM 04OCN1 68430 Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices TABLE 1—Continued Application No. Drug ANDA 074446 .... Terazosin HCl Tablets, EQ 1 mg base, EQ 2 mg base, EQ 5 mg base, and EQ 10 mg base. Diclofenac Sodium Delayed-Release Tablets USP, 25 mg, 50 mg, and 75 mg. Hydroxyurea Capsules USP, 500 mg ...................................... ANDA 074459 .... ANDA 074476 .... ANDA 074504 .... Applicant ANDA 074537 .... ANDA 074555 .... ANDA 074674 .... Tamoxifen Citrate Tablets USP, EQ 10 mg base and EQ 20 mg base. Selegiline HCl Tablets USP, 5 mg ........................................... Cholestyramine for Oral Suspension USP .............................. Acyclovir Capsules USP, 200 mg ............................................ ANDA ANDA ANDA ANDA 074745 074771 074847 074883 .... .... .... .... Megestrol Acetate Tablets USP, 40 mg .................................. Cholestyramine for Oral Suspension USP .............................. Etodolac Tablets USP, 400 mg and 500 mg ........................... Etodolac Tablets USP, 400 mg and 500 mg ........................... ANDA ANDA ANDA ANDA ANDA 074895 074914 074989 075021 075557 .... .... .... .... .... Amiodarone HCl Tablets, 200 mg ........................................... Acyclovir Capsules USP, 200 mg ............................................ Labetalol HCl Tablets USP, 100 mg, 200 mg, and 300 mg .... Acyclovir Tablets USP, 400 mg and 800 mg .......................... Ranitidine HCl Capsules, EQ 150 mg base and EQ 300 mg base. Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg. Sertraline HCl Tablets USP, EQ 25 mg base, EQ 50 mg base, and EQ 100 mg base. Pemoline Tablets, 18.75 mg, 37.5 mg, and 75 mg ................. ANDA 075686 .... ANDA 075719 .... ANDA 075726 .... ANDA 075740 .... ANDA 075810 .... ANDA 075823 .... ANDA 075827 .... ANDA 075862 .... ANDA 075865 .... ANDA 075971 .... ANDA 075975 .... Tamoxifen Citrate Tablets USP, EQ 10 mg base and EQ 20 mg base. Fluoxetine HCl Tablets , EQ 10 mg base ................................ Calcitriol Injection USP, 0.001 mg/mL and 0.002 mg/mL ....... Gabapentin Tablets USP, 600 mg and 800 mg ...................... Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/ 0.02 mg. Fluoxetine HCl Tablets , EQ 10 mg base and EQ 40 mg base. Metformin HCl Tablets USP, 500 mg, 850 mg, and 1 g ......... ANDA 076244 .... Metformin HCl Tablets USP, 500 mg, 625 mg, 750 mg, 850 mg, and 1 g. Pergolide Mesylate Tablets, EQ 0.05 mg base, EQ 0.25 mg base, and EQ 1 mg base. Alendronate Sodium Tablets USP, EQ 35 mg tablets and EQ 70 mg tablets. Balziva-21 Tablets (norethindrone and ethinyl estradiol tablets USP), 0.4 mg/0.035 mg. Mirtazapine Tablets USP, 15 mg, 30 mg, and 45 mg ............. ANDA 076251 .... Fluoxetine HCl Capsules, EQ 40 mg base .............................. ANDA 076328 .... ANDA 076340 .... Metformin HCl Tablets USP, 500 mg, 850 mg, and 1 g ......... Finasteride Tablets USP, 5 mg ................................................ ANDA 076426 .... ANDA 076496 .... Ciprofloxacin HCl Tablets , EQ 100 mg base, EQ 250 mg base, EQ 500 mg base, and EQ 750 mg base. Metformin HCl Extended-Release Tablets USP, 500 mg ....... ANDA 076545 .... Metformin HCl Extended-Release Tablets USP, 500 mg ....... ANDA 076840 .... Sumatriptan Succinate Tablets, EQ 25 mg base, EQ 50 mg base, and EQ 100 mg base. Nicotine Polacrilex Gum USP, EQ 2 mg base ........................ ANDA 076094 .... ANDA 076184 .... mstockstill on DSK3G9T082PROD with NOTICES ANDA 076198 .... ANDA 076880 .... ANDA 076945 .... ANDA 077020 .... ANDA 077082 .... VerDate Sep<11>2014 Fosinopril Sodium and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg and 20 mg/12.5 mg. Cilostazol Tablets USP, 100 mg .............................................. Paroxetine Tablets USP, EQ 10 mg base, EQ 20 mg base, EQ 30 mg base, and EQ 40 mg base. 19:01 Oct 03, 2016 Jkt 241001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Do. Do. Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228. Teva Pharmaceuticals USA, Inc. G&W Laboratories, Inc. Teva Pharmaceuticals, USA, Inc. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Teva Pharmaceuticals USA, Inc. Do. Do. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Teva Pharmaceuticals USA, Inc. Do. Do. Do. Do. Do. Do. Mallinckrodt Inc., 675 McConnell Blvd., Hazelwood, MO 63042. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Teva Parenteral Medicines, Inc. Teva Pharmaceuticals USA, Inc. Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Do. Teva Pharmaceuticals USA, Inc. Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Teva Pharmaceuticals USA, Inc. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Barr Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Teva Pharmaceuticals USA, Inc. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Teva Pharmaceuticals USA, Inc. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Teva Pharmaceuticals USA, Inc. E:\FR\FM\04OCN1.SGM 04OCN1 Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices 68431 TABLE 1—Continued Application No. Drug ANDA 077775 .... ANDA 077850 .... Fentanyl Extended-Release Film, 25 micrograms (mcg), 50 mcg, 75 mcg, and 100 mcg. Nicotine Polacrilex Gum USP, EQ 4 mg base ........................ ANDA 077898 .... Cilostazol Tablets USP, 50 mg and 100 mg ........................... ANDA 077973 .... Bicalutamide Tablets USP, 50 mg ........................................... ANDA 077995 .... Bicalutamide Tablets UPS, 50 mg ........................................... ANDA 078079 .... ANDA 078221 .... Ciclopirox Topical Solution USP, 8% ....................................... Granisetron HCl Tablets USP, EQ 1 mg base ........................ ANDA 078263 .... Perindopril Erbumine Tablets, 2 mg, 4 mg, and 8 mg ............ ANDA 078567 .... Ciclopirox Topical Solution USP, 8% ....................................... ANDA 078666 .... Levonorgestrel Tablets, 0.75 mg ............................................. ANDA 078773 .... ANDA 080400 .... ANDA 080828 .... Atorvastatin Calcium Tablets, EQ 10 mg base, EQ 20 mg (base), EQ 40 mg base, and EQ 80 mg base. Hydrocortisone Cream USP ..................................................... Hydrocortisone Acetate Ophthalmic Ointment USP, 0.5% ...... ANDA 083919 .... Meprobamate Tablets USP, 600 mg ....................................... ANDA 085022 .... Hydrochlorothiazide Tablets USP, 100 mg .............................. ANDA 085855 .... ANDA 087264 .... ANDA 087665 .... A-Methapred (methylprednisolone sodium succinate for Injection USP), EQ 125 mg base/vial. Ergotamine Tartrate Sublingual Tablets USP, 2 mg ............... Orgatrax (hydroxyzine HCl Injection USP), 25 mg/mL and 50 mg/mL. Thioridazine HCl Tablets USP, 25 mg ..................................... Sulfinpyrazone Tablets USP, 100 mg ...................................... ANDA 087666 .... ANDA 087760 .... Sulfinpyrazone Capsules USP, 200 mg .................................. Hydroxyzine Pamoate Capsules USP, EQ 50 mg HCl ........... ANDA ANDA ANDA ANDA ANDA ANDA 088900 .... Hydroxyzine Pamoate Capsules USP, EQ 25 mg HCl ........... Thioridazine HCl Tablets USP, 50 mg ..................................... Thioridazine HCl Tablets USP, 10 mg ..................................... Thioridazine HCl Tablets USP, 100 mg ................................... Dexamethasone Sodium Phosphate Injection USP, EQ 10 mg Phosphate/mL. Doxylamine Succinate Tablets USP, 25 mg ............................ ANDA 088902 .... Chlorthalidone Tablets USP, 25 mg ........................................ ANDA ANDA ANDA ANDA .... .... .... .... Chlorthalidone Tablets USP, 50 mg ........................................ Procainamide HCl Extended-Release Tablets USP, 500 mg Promethazine HCl Tablets USP, 25 mg .................................. Melphalan HCl for Injection, EQ 50 mg base/vial ................... ANDA 090924 .... ANDA 091242 .... Ibutilide Fumarate Injection, 0.1 mg/mL .................................. Anastrozole Tablets USP, 1 mg .............................................. ANDA 091638 .... ANDA 200792 .... Letrozole Tablets USP, 2.5 mg ................................................ Oxymorphone HCl Extended-Release Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg. Zidovudine Injection USP, 10 mg/mL ...................................... ANDA 086750 .... ANDA 087014 .... 087761 088370 088375 088379 088469 088903 088974 089109 090299 .... .... .... .... .... mstockstill on DSK3G9T082PROD with NOTICES ANDA 204538 .... 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 VerDate Sep<11>2014 19:01 Oct 03, 2016 Jkt 241001 Applicant Noven, Pharmaceuticals, Inc. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Pliva Hrvatska DOO, c/o Teva Pharmaceuticals USA, Inc.,425 Privet Rd., Horsham, PA 19044. Synthon Pharmaceuticals, Inc., 9000 Development Dr., P.O. Box 110487, Research Triangle Park, NC 27709. Kudco Ireland Limited, c/o Kremers Urban Pharmaceuticals, Inc., 1101 C Ave. West, Seymour, IN 47274. Teva Pharmaceuticals USA, Inc. Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Lupin Limited, c/o Lupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 21st Floor, Baltimore, MD 21202. Mylan Pharmaceuticals Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504. Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880. Teva Pharmaceuticals USA, Inc. Do. Fera Pharmaceuticals LLC, 134 Birch Hill Rd., Locust Valley, NY 11560. Meda Pharmaceuticals Inc., 265 Davidson Ave., Suite 400, Somerset, NJ 08873. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Hospira, Inc. Organon USA, Inc. Do. Mutual Pharmaceutical Co., Inc. Barr Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Do. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Do. Mutual Pharmaceutical Co., Inc. Do. Do. Fresenius Kabi USA, LLC. Copley Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Do. ANI Pharmaceuticals, Inc.,. Teva Pharmaceuticals USA, Inc. Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103. Do. Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. Do. Par Pharmaceutical, Inc. Liaoning Chengda Biotechnology Co., Ltd., c/o Ruby Pharma, Inc., 116 Village Blvd, Suite 200, Princeton, NJ 08540. Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in table 1 in this document, and all PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 amendments and supplements thereto, is hereby withdrawn, effective November 3, 2016. Introduction or delivery for introduction into interstate E:\FR\FM\04OCN1.SGM 04OCN1 68432 Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices 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. Dated: September 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–23893 Filed 10–3–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–2880] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. SUMMARY: The meeting will be held on November 9 and 10, 2016, from 8 a.m. to 6 p.m. DATES: Gaithersburg Holiday Inn Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD 20879. The hotel’s telephone number is 301–948–8900. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. You may submit comments as follows: mstockstill on DSK3G9T082PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 19:01 Oct 03, 2016 Jkt 241001 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2016–N–2880 for ‘‘Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, aden.asefa@fda.hhs.gov, 301–796–0400, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On November 9, 2016, during session one, the committee will E:\FR\FM\04OCN1.SGM 04OCN1

Agencies

[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Pages 68427-68432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23893]



[[Page 68427]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0002]


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

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.

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.

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 Sec.  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 Sec.  314.150(c) is without prejudice to refiling.

                                 Table 1
------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 005264.............  Heparin Sodium           Hospira, Inc., 275
                          Injection.               North Field Dr.,
                                                   Bldg. H2-2, Lake
                                                   Forest, IL 60045-
                                                   5046.
NDA 009470.............  Xylocaine Viscous        Fresenius Kabi USA
                          (lidocaine               LLC, Three Corporate
                          hydrochloride (HCl))     Dr., Lake Zurich, IL
                          Solution.                60047.
NDA 009698.............  Miltown (meprobamate)    Meda Pharmaceuticals,
                          Tablets, 200             Inc., 265 Davidson
                          milligrams (mg) and      Ave., Suite 300,
                          400 mg.                  Somerset, NJ 08873-
                                                   4120.
NDA 009939.............  Senokot Granules         Purdue Products, L.P.,
                          (sennosides), 15 mg.     One Stamford Forum,
                                                   Stamford, CT 06901.
NDA 010382.............  Tempra (acetaminophen)   Bristol-Myers Squibb
                          Syrup, 160 mg/5          Co., P.O. Box 4000,
                          milliliters (mL).        Princeton, NJ 88543-
                                                   4000.
NDA 011228.............  Liquamar                 Organon USA Inc.,
                          (phenprocoumon)          Subsidiary of Merck &
                          Tablets.                 Co., Inc., 2000
                                                   Galloping Hill Rd.,
                                                   Kenilworth, NJ 07033.
NDA 011613.............  Ionamin (phentermine     UCB, Inc., 1950 Lake
                          resin complex)           Park Dr., Smyrna, GA
                          Capsules, 15 mg and 30   30080.
                          mg.
NDA 011738.............  Numorphan (oxymorphone   Endo Pharmaceuticals,
                          HCl) Suppositories, 5    Inc., 100 Endo Blvd.,
                          mg.                      Chadds Ford, PA
                                                   19317.
NDA 012365.............  Soma Compound            Meda Pharmaceuticals,
                          (carisoprodol and        Inc.
                          aspirin) Tablets.
NDA 012940.............  Isordil (isosorbide      Valeant International
                          dinitrate) Sublingual    Bermuda, c/o Valeant
                          Tablets, 2.5 mg, 5 mg,   Pharmaceuticals North
                          and 10 mg.               America, LLC, 400
                                                   Somerset Corporate
                                                   Blvd., Bridgewater,
                                                   NJ 08807.
NDA 013483.............  Drixoral/Disophrol       Merck Consumer Care,
                          (dexbrompheniramine      556 Morris, Ave.,
                          maleate and              Summit, NJ 07901.
                          pseudoephedrine
                          sulfate) Extended-
                          Release Tablets, 6 mg/
                          120 mg.
NDA 014005.............  Maxibolin                Organon USA Inc.
                          (ethylestrenol)
                          Tablets.
NDA 017087.............  Ethrane (enflurane USP)  Baxter Healthcare
                                                   Corp., 32650 N.
                                                   Wilson Rd., Round
                                                   Lake, IL 60073.
NDA 017689.............  Methadone HCl Syrup....  Sandoz, Inc., 4700
                                                   Sandoz, Dr., Wilson,
                                                   NC 27893.
NDA 018766.............  Ansaid (flurbiprofen)    Pharmacia & Upjohn
                          Tablets, 50 mg and 100   Co., c/o Pfizer,
                          mg.                      Inc., 235 East 42nd
                                                   St., New York, NY
                                                   10017.
NDA 018812.............  Sulfamethoxazole and     Teva Pharmaceuticals
                          Trimethoprim Oral        USA, Inc., 1090
                          Suspension USP, 200 mg/  Horsham Rd., P.O. Box
                          5 mL and 40 mg/5 mL.     1090, North Wales, PA
                                                   19454.
NDA 019304.............  Tricor (fenofibrate)     AbbVie Inc., 1 N.
                          Micronized Capsules,     Waukegan Rd., Dept.
                          67 mg, 134 mg, and 200   PA77/Bldg. AP30,
                          mg.                      North Chicago, IL
                                                   60064.
NDA 019384.............  Noroxin (norfloxacin)    Merck Sharp & Dohme
                          Tablets, 400 mg.         Corp., 351 North
                                                   Sumneytown Pike, P.O.
                                                   Box 1000, North
                                                   Wales, PA 19454.
NDA 020005.............  Cardene SR (nicardipine  Chiesi USA, Inc., 1255
                          HCl) Extended-Release    Crescent Green Dr.,
                          Capsules, 30 mg, 45      Suite 250, Cary, NC
                          mg, and 60 mg.           27518.
NDA 020073.............  Romazicon (flumazenil)   Hoffman-LaRoche, Inc.,
                          Injection.               c/o Genetech, Inc., 1
                                                   DNA Way MS #241B,
                                                   South San Francisco,
                                                   CA 94080-4900.
NDA 020084.............  Iobenguane Sulfate I-    Pharmalucence, 10
                          131 Injection, 2.3       DeAngelo Dr.,
                          millicuries.             Bedford, MA 01730.
NDA 020107.............  Novamine (amino acids)   Baxter Healthcare
                          Injection.               Corp.
NDA 020229.............  Leustatin (cladribine)   Janssen
                          Injection, 1 mg/mL.      Pharmaceuticals Inc.,
                                                   920 Route 202 South,
                                                   P.O. Box 300,
                                                   Raritan, NJ 08869-
                                                   0602.
NDA 020251.............  Zantac (ranitidine HCl)  Glaxo Group Limited,
                          Effervescent Tablets,    England d/b/a
                          25 mg and 150 mg         GlaxoSmithKline, Five
                          Zantac (ranitidine       Moore Dr., P.O. Box
                          HCl) Effervescent        13398, Research
                          Granules, 150 mg.        Triangle Park, NC
                                                   27709.
NDA 020312.............  Univasc (moexipril HCl)  UCB, Inc.
                          Tablets, 7.5 mg and 15
                          mg.
NDA 020346.............  Zyrtec (cetirizine HCl)  Johnson and Johnson
                          Syrup, 1 mg/mL.          Consumer Inc., McNeil
                                                   Consumer Healthcare
                                                   Division, 7050 Camp
                                                   Hill Rd., Fort
                                                   Washington, PA 19034-
                                                   2299.
NDA 020410.............  Gastromark (ferumoxsil)  AMAG Pharmaceuticals,
                          Oral Suspension.         100 Haydon Ave.,
                                                   Lexington, MA 02421.

[[Page 68428]]

 
NDA 020416.............  Feridex I.V.             Do.
                          (ferumoxides)
                          Injection.
NDA 020460.............  Cytovene (ganciclovir)   Roche Palo Alto LLC, c/
                          Capsules, 250 mg and     o Genentech, Inc., 1
                          500 mg.                  DNA Way, MS#241B,
                                                   South San Francisco,
                                                   CA 94080-4990.
NDA 020575.............  DentiPatch (lidocaine).  Noven Pharmaceuticals,
                                                   Inc., 11960 SW. 144th
                                                   St., Miami, FL 33186.
NDA 020638.............  Vistide (cidofovir)      Gilead Sciences, Inc.,
                          Injection, Equivalent    333 Lakeside Dr.,
                          to (EQ) 75 mg base/mL.   Foster City, CA
                                                   94404.
NDA 020729.............  Uniretic (moexipril HCl  UCB, Inc.
                          and
                          hydrochlorothiazide)
                          Tablets, 7.5 mg/12.5
                          mg, 15 mg/12.5 mg, and
                          15 mg/25 mg.
NDA 021044.............  Palladone                Rhodes Pharmaceuticals
                          (hydromorphone HCl)      L.P., 498 Washington
                          Extended-Release         St., Coventry, RI
                          Capsules.                02816.
NDA 021046.............  Celexa (citalopram       Forest Laboratories,
                          hydrobromide) EQ 10 mg   Inc., Harborside
                          base/5 mL Oral           Financial Center,
                          Solution.                Plaza V, Suite 1900,
                                                   Jersey, City, NJ
                                                   07311.
NDA 021378.............  Combunox (Oxycodone HCl  Do.
                          and Ibuprofen) Tablets.
NDA 021671.............  DepoDur (morphine        Pacira
                          sulfate) Extended-       Pharmaceuticals,
                          Release Injection.       Inc., 10450 Science
                                                   Center Dr., San
                                                   Diego, CA 92121.
NDA 021693.............  Rybix ODT (tramadol      Shionogi, Inc., 300
                          HCl) Orally              Campus Dr., Suite
                          Disintegrating Tablets.  300, Florham Park, NJ
                                                   07932.
NDA 021768.............  Fludeoxyglucose F18      Weill Medical College
                          (FDG) Injection.         of Cornell
                                                   University, c/o
                                                   Citigroup Biomedical
                                                   Imaging Center, 516
                                                   East 72nd St., New
                                                   York, NY 10021.
NDA 022244.............  Lusedra (fospropofol     Eisai, Inc., 155 Tice
                          disodium) Injection.     Blvd., Woodcliff
                                                   Lake, NJ 07677.
NDA 022312.............  Docetaxel Injection....  Apotex Inc., c/o
                                                   Apotex Corp., 2400
                                                   North Commerce
                                                   Parkway, Suite 400,
                                                   Weston, FL 33326.
ANDA 040223............  Acetaminophen and        Barr Laboratories,
                          Codeine Phosphate        Inc., Subsidiary of
                          Tablets USP, 300 mg/15   Teva Pharmaceuticals
                          mg, 300 mg/30 mg, and    USA, Inc., 425 Privet
                          300 mg/60 mg.            Rd., Horsham, PA
                                                   19044.
ANDA 040297............  Estradiol Tablets USP,   Upsher-Smith
                          0.5 mg, 1 mg, and 2 mg.  Laboratories, Inc.,
                                                   6701 Evenstad Dr.,
                                                   Maple Grove, MN
                                                   55369.
ANDA 040311............  Medroxyprogesterone      Duramed
                          Acetate Tablets USP,     Pharmaceuticals,
                          2.5 mg, 5 mg, and 10     Inc., Subsidiary of
                          mg.                      Teva Pharmaceuticals
                                                   USA Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 040318............  Meperidine HCl Tablets   Do.
                          USP, 50 mg and 100 mg.
ANDA 040472............  Dextroamphetamine        Teva Pharmaceuticals
                          Saccharate,              USA, Inc., 425 Privet
                          Amphetamine Aspartate,   Rd., Horsham, PA
                          Dextroamphetamine        19044.
                          Sulfate, and
                          Amphetamine Sulfate
                          Tablets.
NDA 050143.............  Chloromycetin            Parkedale
                          (chloramphenicol         Pharmaceuticals,
                          ophthalmic solution      Inc., c/o King
                          USP) Ophthalmic          Pharmaceuticals,
                          Solution.                Inc., 501 Fifth St.,
                                                   Bristol, TN 37620.
NDA 050156.............  Chloromycetin            Do.
                          (chloramphenicol
                          ophthalmic ointment
                          USP) Ophthalmic
                          Ointment, 1%.
NDA 050443.............  Blenoxane (bleomycin     Bristol-Myers Squibb
                          sulfate) for             Co.
                          Injection, EQ 15 units
                          base/vial and 30 units
                          base/vial.
NDA 050630.............  Primaxin (imipenem and   Merck, Sharp & Dohme
                          cilastatin sodium)       Corp.
                          Powder, EQ 500 mg base/
                          vial; 500 mg/vial and
                          EQ 750 mg base/vial;
                          750 mg/vial.
ANDA 060306............  Penicillin G Potassium   Teva Pharmaceuticals
                          Tablets USP.             USA, Inc.
ANDA 060307............  Penicillin G Potassium   Do.
                          for Oral Solution USP.
ANDA 061969............  Cephalexin Capsules      Ivax Pharmaceuticals,
                          USP, EQ 250 mg base      Inc., Subsidiary of
                          and EQ 500 mg base.      Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 062240............  Cloxacillin Sodium       Teva Pharmaceuticals
                          Capsules USP, EQ 250     USA, Inc.
                          mg base and EQ 500 mg
                          base.
ANDA 062252............  Oxacillin Sodium for     Teva Pharmaceuticals
                          Oral Solution USP, EQ    USA, Inc.
                          250 mg base/5 mL.
ANDA 062268............  Cloxacillin Sodium for   Do.
                          Oral Solution USP, EQ
                          125 mg base/5 mL.
ANDA 062653............  Doryx (doxycycline       Warner Chilcott Co.,
                          hyclate) Delayed-        LLC, c/o Warner
                          Release Capsules, EQ     Chilcott (US), LLC,
                          100 mg base.             100 Enterprise Dr.,
                                                   Rockaway, NJ 07866.
ANDA 062670............  Nystatin Oral            Teva Pharmaceuticals
                          Suspension USP,          USA, Inc.
                          100,000 units/mL.
ANDA 062683............  Cephradine Capsules      Do.
                          USP, 250 mg and 500 mg.
ANDA 062695............  Cefadroxil Capsules      Do.
                          USP, EQ 500 mg base.
ANDA 062751............  Erythromycin Pledgets    Ivax Pharmaceuticals,
                          USP, 2%.                 Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 062760............  Cephalexin Capsules      Teva Pharmaceuticals
                          USP, EQ 250 mg base.     USA, Inc.
ANDA 062761............  Cephalexin Capsules      Do.
                          USP, EQ 500 mg base.
ANDA 062766............  Cefadroxil Capsules      Ivax Pharmaceuticals,
                          USP, EQ 500 mg base.     Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 062767............  Cephalexin for Oral      Teva Pharmaceuticals
                          Suspension USP, EQ 125   USA, Inc.
                          mg base/5 mL.
ANDA 062768............  Cephalexin for Oral      Do.
                          Suspension USP, EQ 250
                          mg base/5 mL.
ANDA 062775............  Cephalexin Capsules      Barr Laboratories,
                          USP, EQ 500 mg base.     Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 062853............  Amoxicillin Capsules     Teva Pharmaceuticals
                          USP, 250 mg.             USA, Inc.
ANDA 062854............  Amoxicillin Capsules     Do.
                          USP, 500 mg.
ANDA 062946............  Amoxicillin for Oral     Do.
                          Suspension USP, 125 mg/
                          5 mL.
ANDA 063001............  Amoxicillin for Oral     Do.
                          Suspension USP, 250 mg/
                          5 mL.

[[Page 68429]]

 
ANDA 063018............  Cefazolin Sodium for     Do.
                          Injection USP, EQ 5
                          grams (g) base/vial
                          and EQ 10 g base/vial.
ANDA 063027............  Clindamycin HCl          Do.
                          Capsules USP, EQ 75 mg
                          base.
ANDA 063030............  Amoxicillin Capsules     Do.
                          USP, 250 mg.
ANDA 063031............  Amoxicillin Capsules     Do.
                          USP, 500 mg.
ANDA 064031............  Amoxicillin Chewable     Do.
                          Tablets, 125 mg and
                          250 mg.
ANDA 064081............  Cefaclor Capsules USP,   Do.
                          EQ 250 mg base and EQ
                          500 mg base.
ANDA 064145............  Cefaclor Capsules USP,   Do.
                          EQ 250 mg base and EQ
                          500 mg base.
ANDA 065137............  Clarithromycin Tablets   Ivax Pharmaceuticals,
                          USP, 250 mg and 500 mg.  Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 070006............  Sulfamethoxazole and     Mutual Pharmaceutical
                          Trimethoprim Tablets     Co., Inc., 1100
                          USP, 400 mg/80 mg.       Orthodox St.,
                                                   Philadelphia, PA
                                                   19124.
ANDA 070007............  Sulfamethoxazole and     Do.
                          Trimethoprim Tablets
                          USP, 800 mg/160 mg.
ANDA 070232............  Propranolol HCl Tablets  Teva Pharmaceuticals
                          USP, 10 mg.              USA, Inc.
ANDA 070234............  Propranolol HCl Tablets  Do.
                          USP, 40 mg.
ANDA 070266............  Indo-Lemmon              Do.
                          (Indomethacin Capsules
                          USP), 25 mg.
ANDA 070267............  Indo-Lemmon              Do.
                          (Indomethacin Capsules
                          USP), 50 mg.
ANDA 070469............  Ibuprohn (Ibuprofen      Ohm Laboratories,
                          Tablets USP), 400 mg.    Inc., c/o Ranbaxy
                                                   Inc., 600 College Rd.
                                                   East, Princeton, NJ
                                                   08540.
ANDA 070618............  Potassium Chloride       Copley Pharmaceutical,
                          Extended-Release         Inc., Subsidiary of
                          Tablets USP, 8           Teva Pharmaceuticals
                          milliequivalents.        USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 070660............  Metoclopramide HCl       Mutual Pharmaceutical
                          Tablets USP, EQ 10 mg    Co., Inc.
                          base.
ANDA 071145............  Ibuprofen Tablets USP..  Ivax Pharmaceuticals,
                                                   Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 071146............  Ibuprofen Tablets USP,   Do.
                          600 mg.
ANDA 071184............  Thiothixene HCl Oral     Teva Pharmaceuticals
                          Solution USP, EQ 5 mg    USA, Inc.
                          base/mL.
ANDA 071342............  Indomethacin Capsules    Do.
                          USP, 25 mg.
ANDA 071343............  Indomethacin Capsules    Do.
                          USP, 50 mg.
ANDA 072438............  Fenoprofen Calcium       Par Pharmaceutical,
                          Capsules USP, EQ 300     Inc., One Ram Ridge
                          mg base.                 Rd., Spring Valley,
                                                   NY 10977.
ANDA 072522............  Fluocinonide Topical     Teva Pharmaceuticals
                          Solution USP, 0.05%.     USA, Inc.
ANDA 072600............  Clofibrate Capsules      Do.
                          USP, 500 mg.
ANDA 072692............  Norethindrone and        Barr Laboratories,
                          Ethinyl Estradiol        Inc., Subsidiary of
                          Tablets USP, 0.5 mg/     Teva Pharmaceuticals,
                          0.035 mg.                USA, Inc.
ANDA 072999............  Dopamine HCl Injection   Teva Parenteral
                          USP, 200 mg/5 mL.        Medicines, Inc., 425
                                                   Privet Rd., Horsham,
                                                   PA 19044.
ANDA 073005............  Cinoxacin Capsules USP,  Teva Pharmaceuticals
                          250 mg.                  USA, Inc.
ANDA 073006............  Cinoxacin Capsules USP,  Do.
                          500 mg.
ANDA 073043............  Baclofen Tablets USP,    Do.
                          10 mg.
ANDA 073044............  Baclofen Tablets USP,    Do.
                          20 mg.
ANDA 073099............  Leucovorin Calcium       Pharmachemie B.V.,
                          Tablets USP, EQ 5 mg     Subsidiary of Teva
                          base.                    Pharmaceuticals USA,
                                                   Inc., 425 Privet Rd.,
                                                   Horsham, PA 19044.
ANDA 073101............  Leucovorin Calcium       Do.
                          Tablets USP, EQ 25 mg
                          base.
ANDA 073141............  Ibuprofen Tablets USP,   Teva Pharmaceuticals
                          200 mg.                  USA, Inc.
ANDA 073315............  Atenolol Tablets USP,    Do.
                          50 mg.
ANDA 073316............  Atenolol Tablets USP,    Do.
                          100 mg.
ANDA 073343............  Ibuprofen Tablets USP,   Do.
                          400 mg.
ANDA 073344............  Ibuprofen Tablets USP,   Do.
                          600 mg.
ANDA 073345............  Ibuprofen Tablets USP,   Do.
                          800 mg.
ANDA 073515............  Ketoprofen Capsules      Do.
                          USP, 25 mg.
ANDA 073679............  Diflunisal Tablets USP,  Do.
                          250 mg.
ANDA 074067............  Diltiazem HCl Tablets    Do.
                          USP, 30 mg, 60 mg, 90
                          mg, and 120 mg.
ANDA 074107............  Atenolol and             Pliva, Inc.,
                          Chlorthalidone Tablets   Subsidiary of Teva
                          USP, 50 mg/25 mg and     Pharmaceuticals USA,
                          100 mg/25 mg.            Inc., 425 Privet Rd.,
                                                   Horsham, PA 19044.
ANDA 074120............  Atenolol Tablets USP,    Teva Pharmaceuticals
                          50 mg and 100 mg.        USA, Inc.
ANDA 074123............  Pindolol Tablets USP, 5  G&W Laboratories,
                          mg and 10 mg.            Inc., 111 Coolidge
                                                   St., South
                                                   Plainfield, NJ 07080.
ANDA 074124............  Ciprofloxacin HCl        Barr Laboratories,
                          Tablets, EQ 250 mg       Inc., Subsidiary of
                          base, EQ 500 mg base,    Teva Pharmaceuticals
                          and EQ 750 mg base.      USA, Inc.
ANDA 074143............  Metoprolol Tartrate      Teva Pharmaceuticals
                          Tablets USP, 50 mg and   USA, Inc.
                          100 mg.
ANDA 074216............  Naproxen Tablets, 250    Do.
                          mg, 375 mg, and 500 mg.
ANDA 074294............  Alprazolam Tablets USP,  Ivax Pharmaceuticals,
                          0.25 mg, 0.5 mg, 1 mg,   Inc., Subsidiary of
                          and 2 mg.                Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 074333............  Metoprolol Tartrate      Teva Pharmaceuticals
                          Tablets USP, 50 mg and   USA, Inc.
                          100 mg.
ANDA 074357............  Trazodone HCl Tablets    Do.
                          USP, 150 mg.
ANDA 074365............  Cimetidine Tablets USP,  Do.
                          200 mg, 300 mg, 400
                          mg, and 800 mg.

[[Page 68430]]

 
ANDA 074446............  Terazosin HCl Tablets,   Do.
                          EQ 1 mg base, EQ 2 mg
                          base, EQ 5 mg base,
                          and EQ 10 mg base.
ANDA 074459............  Diclofenac Sodium        Do.
                          Delayed-Release
                          Tablets USP, 25 mg, 50
                          mg, and 75 mg.
ANDA 074476............  Hydroxyurea Capsules     Roxane Laboratories,
                          USP, 500 mg.             Inc., 1809 Wilson
                                                   Rd., Columbus, OH
                                                   43228.
ANDA 074504............  Tamoxifen Citrate        Teva Pharmaceuticals
                          Tablets USP, EQ 10 mg    USA, Inc.
                          base and EQ 20 mg base.
ANDA 074537............  Selegiline HCl Tablets   G&W Laboratories, Inc.
                          USP, 5 mg.
ANDA 074555............  Cholestyramine for Oral  Teva Pharmaceuticals,
                          Suspension USP.          USA, Inc.
ANDA 074674............  Acyclovir Capsules USP,  Ivax Pharmaceuticals,
                          200 mg.                  Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 074745............  Megestrol Acetate        Teva Pharmaceuticals
                          Tablets USP, 40 mg.      USA, Inc.
ANDA 074771............  Cholestyramine for Oral  Do.
                          Suspension USP.
ANDA 074847............  Etodolac Tablets USP,    Do.
                          400 mg and 500 mg.
ANDA 074883............  Etodolac Tablets USP,    Ivax Pharmaceuticals,
                          400 mg and 500 mg.       Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 074895............  Amiodarone HCl Tablets,  Teva Pharmaceuticals
                          200 mg.                  USA, Inc.
ANDA 074914............  Acyclovir Capsules USP,  Do.
                          200 mg.
ANDA 074989............  Labetalol HCl Tablets    Do.
                          USP, 100 mg, 200 mg,
                          and 300 mg.
ANDA 075021............  Acyclovir Tablets USP,   Do.
                          400 mg and 800 mg.
ANDA 075557............  Ranitidine HCl           Do.
                          Capsules, EQ 150 mg
                          base and EQ 300 mg
                          base.
ANDA 075686............  Bisoprolol Fumarate and  Do.
                          Hydrochlorothiazide
                          Tablets USP, 2.5 mg/
                          6.25 mg, 5 mg/6.25 mg,
                          and 10 mg/6.25 mg.
ANDA 075719............  Sertraline HCl Tablets   Do.
                          USP, EQ 25 mg base, EQ
                          50 mg base, and EQ 100
                          mg base.
ANDA 075726............  Pemoline Tablets, 18.75  Mallinckrodt Inc., 675
                          mg, 37.5 mg, and 75 mg.  McConnell Blvd.,
                                                   Hazelwood, MO 63042.
ANDA 075740............  Tamoxifen Citrate        Ivax Pharmaceuticals,
                          Tablets USP, EQ 10 mg    Inc., Subsidiary of
                          base and EQ 20 mg base.  Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 075810............  Fluoxetine HCl Tablets   Barr Laboratories,
                          , EQ 10 mg base.         Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 075823............  Calcitriol Injection     Teva Parenteral
                          USP, 0.001 mg/mL and     Medicines, Inc.
                          0.002 mg/mL.
ANDA 075827............  Gabapentin Tablets USP,  Teva Pharmaceuticals
                          600 mg and 800 mg.       USA, Inc.
ANDA 075862............  Levonorgestrel and       Barr Laboratories,
                          Ethinyl Estradiol        Inc., Subsidiary of
                          Tablets USP, 0.1 mg/     Teva Pharmaceuticals
                          0.02 mg.                 USA, Inc.
ANDA 075865............  Fluoxetine HCl Tablets   Ivax Pharmaceuticals,
                          , EQ 10 mg base and EQ   Inc., Subsidiary of
                          40 mg base.              Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 075971............  Metformin HCl Tablets    Barr Laboratories,
                          USP, 500 mg, 850 mg,     Inc., Subsidiary of
                          and 1 g.                 Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 075975............  Metformin HCl Tablets    Ivax Pharmaceuticals,
                          USP, 500 mg, 625 mg,     Inc., Subsidiary of
                          750 mg, 850 mg, and 1    Teva Pharmaceuticals
                          g.                       USA, Inc.
ANDA 076094............  Pergolide Mesylate       Do.
                          Tablets, EQ 0.05 mg
                          base, EQ 0.25 mg base,
                          and EQ 1 mg base.
ANDA 076184............  Alendronate Sodium       Teva Pharmaceuticals
                          Tablets USP, EQ 35 mg    USA, Inc.
                          tablets and EQ 70 mg
                          tablets.
ANDA 076198............  Balziva-21 Tablets       Barr Laboratories,
                          (norethindrone and       Inc., Subsidiary of
                          ethinyl estradiol        Teva Pharmaceuticals
                          tablets USP), 0.4 mg/    USA, Inc.
                          0.035 mg.
ANDA 076244............  Mirtazapine Tablets      Ivax Pharmaceuticals,
                          USP, 15 mg, 30 mg, and   Inc., Subsidiary of
                          45 mg.                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 076251............  Fluoxetine HCl           Barr Laboratories,
                          Capsules, EQ 40 mg       Inc., Subsidiary of
                          base.                    Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 076328............  Metformin HCl Tablets    Teva Pharmaceuticals
                          USP, 500 mg, 850 mg,     USA, Inc.
                          and 1 g.
ANDA 076340............  Finasteride Tablets      Ivax Pharmaceuticals,
                          USP, 5 mg.               Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 076426............  Ciprofloxacin HCl        Pliva, Inc.,
                          Tablets , EQ 100 mg      Subsidiary of Teva
                          base, EQ 250 mg base,    Pharmaceuticals USA,
                          EQ 500 mg base, and EQ   Inc.
                          750 mg base.
ANDA 076496............  Metformin HCl Extended-  Barr Pharmaceuticals,
                          Release Tablets USP,     Inc., Subsidiary of
                          500 mg.                  Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 076545............  Metformin HCl Extended-  Ivax Pharmaceuticals,
                          Release Tablets USP,     Inc., Subsidiary of
                          500 mg.                  Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 076840............  Sumatriptan Succinate    Teva Pharmaceuticals
                          Tablets, EQ 25 mg        USA, Inc.
                          base, EQ 50 mg base,
                          and EQ 100 mg base.
ANDA 076880............  Nicotine Polacrilex Gum  Ivax Pharmaceuticals,
                          USP, EQ 2 mg base.       Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 076945............  Fosinopril Sodium and    Teva Pharmaceuticals
                          Hydrochlorothiazide      USA, Inc.
                          Tablets USP, 10 mg/
                          12.5 mg and 20 mg/12.5
                          mg.
ANDA 077020............  Cilostazol Tablets USP,  Ivax Pharmaceuticals,
                          100 mg.                  Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 077082............  Paroxetine Tablets USP,  Teva Pharmaceuticals
                          EQ 10 mg base, EQ 20     USA, Inc.
                          mg base, EQ 30 mg
                          base, and EQ 40 mg
                          base.

[[Page 68431]]

 
ANDA 077775............  Fentanyl Extended-       Noven,
                          Release Film, 25         Pharmaceuticals, Inc.
                          micrograms (mcg), 50
                          mcg, 75 mcg, and 100
                          mcg.
ANDA 077850............  Nicotine Polacrilex Gum  Ivax Pharmaceuticals,
                          USP, EQ 4 mg base.       Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 077898............  Cilostazol Tablets USP,  Pliva Hrvatska DOO, c/
                          50 mg and 100 mg.        o Teva
                                                   Pharmaceuticals USA,
                                                   Inc.,425 Privet Rd.,
                                                   Horsham, PA 19044.
ANDA 077973............  Bicalutamide Tablets     Synthon
                          USP, 50 mg.              Pharmaceuticals,
                                                   Inc., 9000
                                                   Development Dr., P.O.
                                                   Box 110487, Research
                                                   Triangle Park, NC
                                                   27709.
ANDA 077995............  Bicalutamide Tablets     Kudco Ireland Limited,
                          UPS, 50 mg.              c/o Kremers Urban
                                                   Pharmaceuticals,
                                                   Inc., 1101 C Ave.
                                                   West, Seymour, IN
                                                   47274.
ANDA 078079............  Ciclopirox Topical       Teva Pharmaceuticals
                          Solution USP, 8%.        USA, Inc.
ANDA 078221............  Granisetron HCl Tablets  Barr Laboratories,
                          USP, EQ 1 mg base.       Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 078263............  Perindopril Erbumine     Lupin Limited, c/o
                          Tablets, 2 mg, 4 mg,     Lupin
                          and 8 mg.                Pharmaceuticals,
                                                   Inc., 111 South
                                                   Calvert St.,
                                                   Harborplace Tower,
                                                   21st Floor,
                                                   Baltimore, MD 21202.
ANDA 078567............  Ciclopirox Topical       Mylan Pharmaceuticals
                          Solution USP, 8%.        Inc., 781 Chestnut
                                                   Ridge Rd., P.O. Box
                                                   4310, Morgantown, WV
                                                   26504.
ANDA 078666............  Levonorgestrel Tablets,  Watson Laboratories,
                          0.75 mg.                 Inc., 311 Bonnie
                                                   Circle, Corona, CA
                                                   92880.
ANDA 078773............  Atorvastatin Calcium     Teva Pharmaceuticals
                          Tablets, EQ 10 mg        USA, Inc.
                          base, EQ 20 mg (base),
                          EQ 40 mg base, and EQ
                          80 mg base.
ANDA 080400............  Hydrocortisone Cream     Do.
                          USP.
ANDA 080828............  Hydrocortisone Acetate   Fera Pharmaceuticals
                          Ophthalmic Ointment      LLC, 134 Birch Hill
                          USP, 0.5%.               Rd., Locust Valley,
                                                   NY 11560.
ANDA 083919............  Meprobamate Tablets      Meda Pharmaceuticals
                          USP, 600 mg.             Inc., 265 Davidson
                                                   Ave., Suite 400,
                                                   Somerset, NJ 08873.
ANDA 085022............  Hydrochlorothiazide      Ivax Pharmaceuticals,
                          Tablets USP, 100 mg.     Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 085855............  A-Methapred              Hospira, Inc.
                          (methylprednisolone
                          sodium succinate for
                          Injection USP), EQ 125
                          mg base/vial.
ANDA 086750............  Ergotamine Tartrate      Organon USA, Inc.
                          Sublingual Tablets
                          USP, 2 mg.
ANDA 087014............  Orgatrax (hydroxyzine    Do.
                          HCl Injection USP), 25
                          mg/mL and 50 mg/mL.
ANDA 087264............  Thioridazine HCl         Mutual Pharmaceutical
                          Tablets USP, 25 mg.      Co., Inc.
ANDA 087665............  Sulfinpyrazone Tablets   Barr Pharmaceuticals,
                          USP, 100 mg.             Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 087666............  Sulfinpyrazone Capsules  Do.
                          USP, 200 mg.
ANDA 087760............  Hydroxyzine Pamoate      Ivax Pharmaceuticals,
                          Capsules USP, EQ 50 mg   Inc., Subsidiary of
                          HCl.                     Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 087761............  Hydroxyzine Pamoate      Do.
                          Capsules USP, EQ 25 mg
                          HCl.
ANDA 088370............  Thioridazine HCl         Mutual Pharmaceutical
                          Tablets USP, 50 mg.      Co., Inc.
ANDA 088375............  Thioridazine HCl         Do.
                          Tablets USP, 10 mg.
ANDA 088379............  Thioridazine HCl         Do.
                          Tablets USP, 100 mg.
ANDA 088469............  Dexamethasone Sodium     Fresenius Kabi USA,
                          Phosphate Injection      LLC.
                          USP, EQ 10 mg
                          Phosphate/mL.
ANDA 088900............  Doxylamine Succinate     Copley
                          Tablets USP, 25 mg.      Pharmaceuticals,
                                                   Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 088902............  Chlorthalidone Tablets   Barr Laboratories,
                          USP, 25 mg.              Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 088903............  Chlorthalidone Tablets   Do.
                          USP, 50 mg.
ANDA 088974............  Procainamide HCl         ANI Pharmaceuticals,
                          Extended-Release         Inc.,.
                          Tablets USP, 500 mg.
ANDA 089109............  Promethazine HCl         Teva Pharmaceuticals
                          Tablets USP, 25 mg.      USA, Inc.
ANDA 090299............  Melphalan HCl for        Mylan Institutional
                          Injection, EQ 50 mg      LLC, 4901 Hiawatha
                          base/vial.               Dr., Rockford, IL
                                                   61103.
ANDA 090924............  Ibutilide Fumarate       Do.
                          Injection, 0.1 mg/mL.
ANDA 091242............  Anastrozole Tablets      Impax Laboratories,
                          USP, 1 mg.               Inc., 30831 Huntwood
                                                   Ave., Hayward, CA
                                                   94544.
ANDA 091638............  Letrozole Tablets USP,   Do.
                          2.5 mg.
ANDA 200792............  Oxymorphone HCl          Par Pharmaceutical,
                          Extended-Release         Inc.
                          Tablets, 5 mg, 7.5 mg,
                          10 mg, 15 mg, 20 mg,
                          30 mg, and 40 mg.
ANDA 204538............  Zidovudine Injection     Liaoning Chengda
                          USP, 10 mg/mL.           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

[[Page 68432]]

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.

    Dated: September 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23893 Filed 10-3-16; 8:45 am]
 BILLING CODE 4164-01-P