AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is withdrawing approval of 121 new drug applications (NDAs) and 161 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES:
The withdrawal is effective on July 21, 2017.
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 § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
Table 1
| Application No. | Drug | Applicant |
|---|---|---|
| NDA 005897 | Folvite (folic acid) Injection, 5 milligrams (mg)/milliliter (mL) | Wyeth Pharmaceuticals Inc., Subsidiary of Pfizer Inc., P.O. Box 8299, Philadelphia, PA 19101-8299. |
| NDA 006343 | Wydase (hyaluronidase) Injection USP | Baxter Healthcare Corp., 32650 N. Wilson Rd., Round Lake, IL 60073. |
| NDA 007390 | Banthine (methantheline bromide) Tablets, 50 mg | Shire Development Inc., 725 Chesterbrook Blvd., Wayne, PA 19087. |
| NDA 008126 | Cortisone Acetate (cortisone acetate) Tablets, 5 mg, 10 mg, and 25 mg; and Injection, 25 mg/mL | Pharmacia & Upjohn Co., Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017. |
| NDA 008732 | Pro-Banthine (propantheline bromide) Tablets, 7.5 mg and 15 mg | Shire Development Inc. |
| NDA 011683 | Thiotepa for Injection, 15 mg/vial | Immunex Corp., Subsidiary of Amgen, 1 Amgen Center Dr., MS 17 1B, Thousand Oaks, CA 91320-1799. |
| NDA 011836 | Presamine (imipramine hydrochloride (HCl)) Tablets USP | Sanofi-Aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ 08807. |
| NDA 012003 | Akineton (biperiden HCl) Tablets, 2 mg | AbbVie Inc., 1 N. Waukegan Rd., Dept. PA77/Bldg. AP30-1, North Chicago, IL 60064. |
| NDA 012421 | Medrol Acetate (methylprednisolone acetate) Topical Ointment, 0.25% and 1% | Pharmacia & Upjohn Co. |
| NDA 013935 | Herplex (idoxuridine) Ophthalmic Solution, 0.1% | Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623-9534. |
| NDA 013993 | Chromitope Sodium (sodium chromate Cr 51) Injection USP, 2 millicuries (mCi)/vial and 200 microcuries (uCi)/mL | Bracco Diagnostics Inc., 259 Prospect Plains Rd., Bldg. H, Monroe Township, NJ 08831. |
| NDA 014006 | Maxibolin (ethylestrenol) Elixir, 2 mg/5 mL | Organon USA, Inc., Subsidiary of Merck & Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033. |
| NDA 014214 | NegGram (nalidixic acid) Tablets USP, 250 mg, 500 mg, and 1 gram (g) | Sanofi-Aventis U.S. LLC, c/o Sanofi U.S. Services Inc., 55 Corporate Dr., Bridgewater, NJ 08807. |
| NDA 014295 | Conray 400 (iothalamate sodium) Injection USP, 66.8% | Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO 63042. |
| NDA 016089 | Rubratope-57 (cyanocobalamin CO-57) Capsules, 0.5-1 uCi and Rubratope-57 Kit (cobalt chloride CO-57, cyanocobalamin, cyanocobalamin CO-57, intrinsic factor) | Bracco Diagnostics Inc. |
| NDA 016672 | Ovral (ethinyl estradiol and norgestrel) Tablets, 0.05 mg/0.5 mg | Wyeth Pharmaceuticals Inc. |
| NDA 016692 | M/6 Sodium Lactate (sodium lactate) Injection USP, 1.87 g/100 mL | Baxter Healthcare Corp. |
| NDA 016696 | Dextrose 10% and Sodium Chloride 0.9% Injection USP in Plastic Container | Do. |
| NDA 016708 | Sodium Chromate Cr 51 Injection, 100 µCi/mL | Mallinckrodt Nuclear Medicine LLC., 2703 Wagner Place, Maryland Heights, MO 63043. |
| NDA 016744 | Noriday 1+50 FE (mestranol and norethindrone) Tablets | GD Searle LLC, Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017. |
| NDA 016806 | Ovral-28 (ethinyl estradiol and norgestrel) Tablets, 0.05 mg/0.5 mg | Wyeth Pharmaceuticals Inc. |
| NDA 016860 | Eskalith (lithium carbonate) Capsules, 300 mg | Noven Therapeutics, LLC., 11960 Southwest 144th St., Miami, FL 33186. |
| NDA 017038 | Sodium Chloride Injection, 20 g/100 mL | B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 18109. |
| NDA 017281 | Technetium Tc99m Generator (Neutron) | Lantheus Medical Imaging, Inc., 331 Treble Cove Rd., North Billerica, MA 01862. |
| NDA 017283 | Xenon Xe 133 Injection, 6.3 mCi/mL | Lantheus Medical Imaging, Inc. |
| NDA 017505 | Noriday (mestranol and norethindrone) Tablets | GD Searle LLC. |
| NDA 017549 | LidoPen (lidocaine HCl) Injection, 10% | Meridian Medical Technologies, Inc., Subsidiary of Pfizer Inc., 235 East 42nd Street, New York, NY 10017. |
| NDA 017576 | Ovcon-50 (ethinyl estradiol and norethindrone ) Tablets USP, 0.05 mg/1 mg | Warner Chilcott Co., LLC, Union Street Road, 195 km 1.1, Fajrado, Puerto Rico 00738. |
| NDA 017670 | Sodium Chloride 0.45% in Plastic Container, Irrigation | Hospira, Inc. 275 North Field Dr., Lake Forest, IL 60045. |
| NDA 017756 | Tylenol (acetaminophen) Suppositories, 120 mg and 650 mg | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, 7050 Camp Hill Rd., Fort Washington, PA 19034. |
| NDA 017748 | Noriday 1+50 (mestranol and norethindrone) Tablets | GD Searle LLC. |
| NDA 018031 | Inderide (propranolol HCl and hydrochlorothiazide) Tablets, 40 mg/25 mg and 80 mg/25 mg | Wyeth Pharmaceuticals Inc. |
| NDA 018039 | Loxitane IM (loxapine HCl) Injection, Equivalent to (EQ) 50 mg base/mL | Actavis Laboratories UT, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Road, Horsham, PA 19044. |
| NDA 018104 | Hylorel (guanadrel sulfate) Tablets, 10 mg and 25 mg | Pharmacia and Upjohn Co. |
| NDA 018239 | Propine (dipivefrin HCl) Ophthalmic Solution USP, 0.1% | Allergan, Inc. |
| NDA 018254 | Ringer's and Dextrose 5% (calcium chloride, dextrose, potassium chloride, sodium chloride) Injection USP (in Plastic Container) | Hospira Inc. |
| NDA 018353 | Flagyl I.V. (metronidazole HCl) for Injection, EQ 500 mg base/vial | GD Searle LLC. |
| NDA 018388 | Lidocaine HCl in Dextrose 5% in Plastic Container Injection | Hospira, Inc. |
| NDA 018404 | 0.25% Acetic Acid Irrigation Solution | Do. |
| NDA 018406 | PhysioSol (magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium gluconate) Irrigation Solution | Do. |
| NDA 018460 | Dialyte (Peritoneal Dialysis Solution) Pattern LM (calcium chloride, dextrose, magnesium chloride, sodium acetate, sodium chloride) with Dextrose | B. Braun Medical Inc. |
| NDA 018465 | Soyacal (soybean oil) Injection, 10% | Grifols Biologicals Inc., 5555 Valley Blvd., Los Angeles, CA 90032. |
| NDA 018509 | Baros (sodium bicarbonate, tartaric acid) Effervescent Granules, 460 mg/g; 420 mg/g) | Mallinckrodt Inc. |
| NDA 018713 | Mycelex (clotrimazole) Troche/Lozenge, 10 mg | Bayer Healthcare Pharmaceuticals Inc., 100 Bayer Blvd., Whippany, NJ 07981. |
| ANDA 018730 | Indomethacin Capsules USP, 25 mg and 50 mg | Zenith Laboratories, Inc., 140 LeGrand Ave., Northvale, NJ 07647. |
| NDA 018786 | Soyacal(Soybean Oil) Injection, 20% | Grifols Biologicals Inc., 5555 Valley Blvd., Los Angeles, CA 90032. |
| NDA 018807 | Dialyte (Peritoneal Dialysis Concentrates) (calcium chloride, dextrose, magnesium chloride, sodium acetate, sodium chloride) with Dextrose | B. Braun Medical Inc. |
| NDA 018887 | Intal (cromolyn sodium) Metered Dose Inhaler, 0.8 mg/inhalation | King Pharmaceuticals Inc., Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017. |
| NDA 018970 | Liposyn III 20% (soybean oil) Injection | Hospira, Inc. |
| NDA 018991 | Liposyn II 20% (safflower oil and soybean oil) Injection | Do. |
| NDA 018997 | Liposyn II 10% (safflower oil and soybean oil) Injection | Do. |
| NDA 019038 | Calan (verapamil HCl) Injection, 2.5 mg/mL | G.D. Searle LLC. |
| NDA 019121 | Bretylium Tosylate in 5% Dextrose Injection | B. Braun Medical Inc. |
| NDA 019212 | Theophylline and 5% Dextrose Injection | Do. |
| NDA 019229 | Zinc Sulfate Injection, EQ 1 mg Zinc/mL | Abraxis Pharmaceutical Products, 6133 North River Rd., Suite 500, Rosemont, IL 60018. |
| NDA 019350 | Cupric Sulfate Injection, EQ 0.4 mg Copper/mL | Do. |
| NDA 019415 | Fertinex (urofollitropin) for Subcutaneous Injection, 75 international units (IU)/ampule and 150 IU/ampule, and Metrodin (urofollitropin) for Intramuscular Injection, 75 IU)/ampule and 150 IU/ampule | EMD Serono, Inc., One Technology Pl., Rockland, MA 02370. |
| NDA 019510 | Pepcid (famotidine) Injection, 10 mg/mL | Merck Sharp & Dohme Corp., Subsidiary of Merck & Co., Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889. |
| NDA 019514 | Ionosol T and 5% Dextrose Injection | Hospira, Inc. |
| NDA 019515 | Ionosol B and 5% Dextrose Injection | Do. |
| NDA 019641 | Terazol 3 (terconazole) Vaginal Suppositories, 80 mg | Janssen Pharmaceuticals, Inc., 1000 U.S. Highway 202, Raritan, NJ 08869. |
| NDA 019643 | Mevacor (lovastatin) Tablets, 10 mg, 20 mg, and 40 mg | Merck Sharp & Dohme Corp. |
| NDA 019660 | Tilade (nedocromil sodium) Metered Dose Inhaler, 1.75 mg/inhalation | King Pharmaceuticals Inc. |
| NDA 019793 | Pharmaseal Scrub Care (chlorhexidine gluconate) Sponge, 4% | CareFusion 2200, Inc., 75 North Fairway Dr., Vernon Hills, IL 60061. |
| NDA 019802 | Heparin Sodium in Sodium Chloride Injection | B. Braun Medical Inc. |
| NDA 019834 | Plendil (felodipine) Extended-Release Tablets, 2.5 mg, 5 mg, and 10 mg | AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803. |
| NDA 019907 | Optipranolol (metipranolol HCl) Ophthalmic Solution, 0.3% | Bausch & Lomb, Inc., Subsidiary of Valeant Pharmaceuticals International, Inc., 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. |
| NDA 019933 | Lactated Ringer's (calcium chloride, potassium chloride, sodium chloride, sodium lactate) Irrigation Solution | Baxter Healthcare Corp. |
| NDA 020092 | Dilacor XR (diltiazem HCl) Extended-Release Capsules, 120 mg, 180 mg, and 240 mg | Allergan Sales, LLC, 2525 Dupont Drive, Irvine, CA 92612. |
| NDA 020146 | Nitrodisc (nitroglycerin) Transdermal System, 0.2 mg/hour (hr), 0.3 mg/hr, and 0.4 mg/hr | GD Searle LLC. |
| NDA 020181 | Liposyn III 30% (soybean oil) Injection | Hospira, Inc. |
| NDA 020249 | Pepcid Preservative Free (famotidine) Injection, 0.4 mg/mL | Merck Sharp & Dohme Corp. |
| NDA 020291 | Combivent (albuterol sulfate and ipratropium bromide) Metered Dose Inhaler, EQ 0.09 mg base/inhalation; 0.018 mg/inhalation | Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877. |
| NDA 020292 | FerriSeltz (ferric ammonium citrate) Powder for Oral Solution, 600 mg/packet | Otsuka Pharmaceutical Co., Ltd., 508 Carnegie Center Dr., Princeton, NJ 08540. |
| ANDA 020360 | Hepatasol Sulfite-free (amino acids) Injection, 8% | Baxter Healthcare Corp. |
| NDA 020409 | Nasarel (flunisolide) Nasal Spray, 0.029 mg/spray | Teva Branded Pharmaceutical Products R&D, Inc., 74 NW 176th St., Miami, FL 33169. |
| NDA 020448 | Imodium A-D (loperamide HCl) Tablets (Chewable), 2 mg | Johnson & Johnson Consumer Inc. |
| NDA 020506 | Tiamate (diltiazem malate) Extended-Release Tablets | Merck & Co., Inc., P.O. Box 1000, UG2C-50, North Wales, PA 19454. |
| NDA 020518 | Retrovir (zidovudine) Tablets, 200 mg and 300 mg | ViiV Healthcare Co., Five Moore Dr., P.O. Box 13398, Research Triangle Park, NC 27709. |
| NDA 020569 | Vitrasert (ganciclovir) Implant, 4.5 mg | Bausch & Lomb Inc. |
| NDA 020606 | Imodium Multi-Symptom Relief (loperamide HCl and simethicone) Tablets (Chewable), 2 mg/125 mg | Johnson & Johnson Consumer Inc. |
| NDA 020635 | Levaquin (levofloxacin) Injection, EQ 250 mg/50 mL, EQ 500 mg/100 mL, and EQ 750 mg/150 mL | Janssen Pharmaceuticals, Inc. |
| NDA 020745 | Zantac (ranitidine HCl) Tablets (Effervescent), EQ 75 mg base | Sanofi-Aventis U.S. LLC, 55 Corporate Drive, Bridgewater, NJ 08807. |
| NDA 020752 | Pepcid RPD (famotidine) Orally Disintegrating Tablets, 20 mg and 40 mg | Merck Sharp & Dohme Corp. |
| NDA 020799 | Floxin Otic (ofloxacin) Otic Solution, 0.3% | Daiichi Sankyo Co., Ltd., 399 Thornall St., Edison, NJ 08837. |
| NDA 020813 | Klonopin (clonazepam) Orally Disintegrating Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 2 mg | Hoffmann La-Roche, Inc., c/o Genentech, Inc., 1 DNA Way MS #242, South San Francisco, CA 94080. |
| NDA 020902 | Pepcid AC (famotidine) Tablets OTC, 10 mg | Johnson & Johnson Consumer Inc. |
| NDA 021097 | Visicol (sodium phosphate, monobasic monohydrate, and sodium phosphate dibasic anhydrous) Tablets USP | Salix Pharmaceuticals Inc., Subsidiary of Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. |
| NDA 021214 | Rescula (unoprostone isopropyl) Ophthalmic Solution, 0.15% | R-Tech Ueno, Ltd., c/o Sucampo Pharma Americas, LLC, 805 King Farm Blvd., Suite 550, Rockville, MD 20850. |
| NDA 021224 | Razadyne (galantamine hydrobromide) Oral Solution, 4 mg/mL | Janssen Pharmaceuticals, Inc. |
| NDA 021317 | Bayer Extra Strength Aspirin (aspirin) Tablets, 500 mg | Bayer Healthcare LLC, 100 Bayer Blvd., Whippany, NJ 07981. |
| NDA 021412 | Tovalt ODT (zolpidem tartrate) Orally Disintegrating Tablets, 5 mg and 10 mg | Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. |
| NDA 021453 | Zerit XR (stavudine) Extended-Release Capsules, 37.5 mg, 50 mg, 75 mg, and 100 mg | Bristol-Myers Squibb Co., 5 Research Parkway, Wallingford, CT 06492. |
| NDA 021483 | Geodon (ziprasidone HCl) Oral Suspension, EQ10 mg base/mL | Pfizer Inc., 235 East 42nd St., New York, NY 10017. |
| NDA 021494 | Axid (nizatidine) Oral Solution, 15 mg/mL | Braintree Laboratories, Inc., 60 Columbian St. West, P.O. Box 850929, Braintree, MA 02185. |
| NDA 021589 | Kemstro (baclofen) Orally Disintegrating Tablets, 10 mg and 20 mg | UCB, Inc.,1950 Lake Park Dr., Smyrna, GA 30080. |
| NDA 021595 | Sanctura (trospium chloride) Tablets, 20 mg | Allergan, Inc. |
| NDA 021721 | Levaquin (levofloxacin) Oral Solution, 25 mg/mL | Janssen Pharmaceuticals, Inc. |
| NDA 021763 | Citalopram Hydrobromide Orally Disintegrating Tablets, EQ 10 mg base, EQ 20 mg base, and EQ 40 mg base | Valeant International (Barbados) SRL Welches, Christ Church, Barbados, BB17154. |
| NDA 021864 | Lybrel (ethinyl estradiol and levonorgestrel) Tablets, 0.02 mg/0.09 mg | Wyeth Pharmaceuticals Inc. |
| NDA 022103 | Sanctura XR (trospium chloride) Extended-Release Capsules, 60 mg | Allergan, Inc. |
| NDA 022220 | Trivaris (triamcinolone acetonide) Injectable Suspension, 80 mg/mL | Do. |
| NDA 022294 | Zidovudine Tablets, 60 mg | Aurobindo Pharma Limited, c/o Aurobindo Pharma USA, Inc., 2400 Route 130 North, Dayton, NJ 08810. |
| NDA 022377 | Alsuma (sumatriptan succinate) Auto-Injector, EQ 6 mg base/0.5 mL Injectable | Meridian Medical Technologies, Inc., 1945 Craig Rd., St. Louis, MO 63146. |
| NDA 022411 | Oleptro (trazodone HCl) Extended-Release Tablets, 150 mg and 300 mg | Angelini Pharma Inc., 8322 Helgerman Ct., Gaithersburg, MD 20877. |
| NDA 022494 | Sodium Fluoride F 18 Injection, 10-200 mCi/mL | National Institutes of Health/National Cancer Institute, Cancer Imaging Program, 9609 Medical Center Dr., Room 4-W236, MSC 9729, Bethesda, MD 20892-9729. |
| NDA 022545 | Tekamlo (aliskiren hemifumarate and amlodipine besylate) Tablets | Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936. |
| ANDA 040032 | Cyclophosphamide Tablets USP, 25 mg and 50 mg | Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228. |
| ANDA 040262 | Leucovorin Calcium for Injection, EQ 350 mg base/vial | Pharmachemie B.V., c/o SICOR Pharmaceuticals, Inc., 19 Hughes, Irvine, CA 92618. |
| ANDA 040772 | Fluorouracil Injection USP, 50 mg/mL | Sandoz Inc., 100 College Road West, Princeton, NJ 08540. |
| ANDA 040793 | A-Methapred (methylprednisolone sodium succinate) for Injection USP, EQ 40 mg base/vial | Hospira, Inc. |
| ANDA 040827 | A-Methapred (methylprednisolone sodium succinate) for Injection USP, EQ 125 mg base/vial | Do. |
| NDA 050182 | Erythrocin (erythromycin lactobionate) for Injection USP | Do. |
| NDA 050435 | Geocillin (carbenicillin indanyl sodium) Tablets, EQ 382 mg base | Pfizer, Inc. |
| NDA 050528 | Duricef (cefadroxil) Tablets USP, EQ 1 g base | Warner Chilcott Co., Inc., 100 Enterprise Drive, Rockaway, NJ 07866. |
| NDA 050545 | Pipracil (piperacillin sodium) Injection | Wyeth Pharmaceuticals Inc. |
| NDA 050590 | Timentin (ticarcillin disodium and clavulanate potassium) for Injection | GlaxoSmithKline. |
| NDA 050658 | Timentin Galaxy Plastic Container(ticarcillin disodium and clavulanate potassium) for Injection | Do. |
| NDA 050664 | Cefzil (cefprozil) Tablets, 250 mg and 500 mg | Corden Pharma Latina, S.p.A. , c/o Clinipace, Inc., 4840 Pearl East Circle, Suite 210E, Boulder, CO 80301. |
| NDA 050665 | Cefzil (cefprozil) Oral Suspension, 125 mg/5 mL and 250 mg/5 mL | Do. |
| ANDA 060076 | Streptomycin Sulfate Powder for Injection, EQ 1 g base/vial and EQ 5 g base/vial | Pfizer Inc. |
| ANDA 060111 | Streptomycin Sulfate Powder for Injection, EQ 1 g base/2.5 mL | Do. |
| ANDA 060607 | Neomycin Sulfate Tablets, 500 mg | Lannett Co., Inc., 9000 State Rd., Philadelphia, PA 19136. |
| ANDA 061578 | Poly-Rx (polymyxin B sulfate USP) for Prescription Compounding | X-GEN Pharmaceuticals, Inc., 300 Daniel Zenker Dr., Horseheads, NY 14845. |
| ANDA 061580 | Baci-Rx (bacitracinUSP) for Prescription Compounding | Do. |
| ANDA 061645 | Econochlor (chloramphenicol) Ophthalmic Solution USP, 0.5% | Alcon Laboratories, Inc., 6201 South Freeway, TC-45, Fort Worth, TX 76134-2099. |
| ANDA 061648 | Chloramphenicol Ophthalmic Ointment, 1% | Do. |
| ANDA 062118 | Cephalexin Capsules USP, EQ 250 mg base and EQ 500 mg base | Do. |
| ANDA 062206 | Cefaclor for Oral Suspension USP, EQ 125 mg base/5 mL, EQ 187 mg base/5 mL, EQ 250 mg base/5 mL, and EQ 375 mg base/5 mL | Do. |
| ANDA 062339 | Statrol (neomycin sulfate and polymyxin B sulfate) Ophthalmic Solution, EQ 3.5 mg base/mL and 16,250 units/mL | Alcon Laboratories, Inc. |
| ANDA 062523 | Gentamicin Sulfate Ophthalmic Solution USP, EQ 0.3% base | Do. |
| ANDA 062628 | Chloramphenicol Ophthalmic Solution USP, 0.5% | Do. |
| ANDA 062691 | Timentin ADD-Vantage (ticarcillin disodium and clavulanate potassium) for Injection USP, EQ 3 g base/vial and EQ 100 mg base/vial | GlaxoSmithKline. |
| ANDA 062714 | Neomycin Sulfate and Dexamethasone Sodium Phosphate Ophthalmic Solution, EQ 3.5 mg base/mL and EQ 0.1% and | Alcon Pharmaceuticals Ltd., 6201 South Freeway, Fort Worth, TX 76134. |
| ANDA 062721 | Neomycin and Polymyxin B Sulfate and Dexamethasone Ophthalmic Suspension USP, EQ 3.5 mg base/mL; 10,000 units/mL; 0.1% | Do. |
| ANDA 062822 | Pediotic (neomycin sulfate and polymyxin B sulfate and hydrocortisone) Otic Suspension USP | Monarch Pharmaceuticals, Inc., Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017-7555. |
| ANDA 063176 | Tobramycin Ophthalmic Solution USP, 0.3% | Alcon Pharmaceuticals, Ltd. |
| ANDA 063208 | Cefazolin for Injection USP, EQ 1 g base/100 mL vial | Steri-Pharma, LLC, 429 South West St., Syracuse, NY 13202. |
| ANDA 063216 | Cefazolin for Injection USP, EQ 500 mg base/100 mL vial | Do. |
| ANDA 063283 | Amikacin Sulfate Injection, EQ 62.5 mg base/mL | Hospira, Inc. |
| ANDA 064169 | Cefazolin for Injection USP, EQ 500 mg base/vial and EQ 1 g base/vial | Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. |
| ANDA 064170 | Cefazolin for Injection USP, EQ 10 g base/vial and EQ 20 g base/vial | Do. |
| ANDA 065010 | Neo-Fradin (neomycin sulfate) Oral Solution USP, EQ 87.5 mg base/5 mL | X-GEN Pharmaceuticals, Inc. |
| ANDA 065011 | Cefoxitin (cefoxitin sodium) for Injection, EQ 10 g base/Vial | Fresenius Kabi USA, LLC. |
| ANDA 065012 | Cefoxitin for Injection USP, EQ 1 g base/vial and EQ 2 g base/vial | Do. |
| ANDA 065245 | Ceftriaxone for Injection USP, EQ 250 mg base/vial, EQ 500 mg base/vial, EQ 1 g base/vial, and EQ 2 g base/vial | Do. |
| ANDA 065252 | Ceftriaxone for Injection, EQ 10 g base/vial | Do. |
| ANDA 065324 | Amoxicillin Tablets for Oral Suspension USP, 200 mg and 400 mg | Aurobindo Pharma Limited. |
| ANDA 065339 | Epirubicin HCl Injection, 50 mg/25 mL and 200 mg/100 mL | Sandoz, Inc. |
| ANDA 065465 | Ceftriaxone for Injection USP, EQ 250 mg base/vial, EQ 500 mg base/vial, EQ 1 g base/vial, and EQ 2 g base/vial | Bedford Laboratories, c/o PAREXEL International, 4600 East-West Highway, Suite 350, Bethesda, MD 20814. |
| ANDA 065475 | Ceftriaxone for Injection USP, EQ 10 g base/vial | Do. |
| ANDA 070088 | Ibuprofen Tablets USP, 600 mg | BASF Corp., 5738 County Rd. 4, Bishop, TX 78343. |
| ANDA 070187 | Disopyramide Phosphate Capsules USP, EQ 150 mg base | Ivax Pharmaceuticals Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Road, Horsham, PA 19044. |
| ANDA 070587 | Bupivacaine HCl Injection USP, 0.75% | Hospira, Inc. |
| ANDA 070659 | Clonidine HCl Tablets, 0.3 mg | Teva Pharmaceuticals USA Inc., 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454. |
| ANDA 070702 | Clonidine HCl Tablets, 0.2 mg | Do. |
| ANDA 070747 | Clonidine HCl Tablets, 0.1 mg | Do. |
| ANDA 070804 | Metaproterenol Sulfate Inhalation Solution USP, 0.6% | Mylan Specialty, L.P., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504. |
| ANDA 071067 | Methyldopa Tablets USP, 500 mg | Teva Pharmaceuticals USA, Inc. |
| ANDA 071101 | Clonidine HCl Tablets USP, 0.3 mg | Duramed Pharmaceuticals, Inc., 2 Quaker Rd., P.O. Box 2900, Pomona, NY 10970. |
| ANDA 071102 | Clonidine HCl Tablets USP, 0.2 mg | Do. |
| ANDA 071103 | Clonidine HCl Tablets USP, 0.1 mg | Do. |
| ANDA 071105 | Methyldopa Tablets USP, 125 mg | Teva Pharmaceuticals USA, Inc. |
| ANDA 071106 | Methyldopa Tablets USP, 250 mg | Do. |
| ANDA 071426 | Vincasar PFS (vincristine sulfate) Injection USP, 1 mg/mL | Teva Parenteral Medicines Inc., 19 Hughes, Irvine, CA 92618. |
| ANDA 071584 | Diazepam Injection USP, 5 mg/mL | Hospira, Inc. |
| ANDA 071786 | Metaproterenol Sulfate Inhalation Solution USP, 0.4% | Mylan Specialty L.P. |
| ANDA 072323 | Acetylcysteine Solution USP, 10% | Roxane Laboratories, Inc. |
| ANDA 072324 | Acetylcysteine Solution USP, 20% | Do. |
| ANDA 073034 | Metaproterenol Sulfate Oral Solution USP, 10 mg/5 mL | G&W Laboratories Inc., 111 Coolidge St., South Plainfield, NJ 07080. |
| ANDA 073636 | Dipivefrin HCl Ophthalmic Solution USP, 0.1% | Alcon Pharmaceuticals, Ltd. |
| ANDA 073676 | Atenolol Tablets, 50 mg and 100 mg | GD Searle LLC. |
| ANDA 074023 | Ranitidine Tablets USP, 150 mg and 300 mg | Mylan Pharmaceuticals Inc. |
| ANDA 074160 | Bumetanide Injection USP, 0.25 mg/mL | Hospira, Inc. |
| ANDA 074269 | Cimetidine in Sodium Chloride 0.9% Injection USP, EQ6 mg base/mL) | Do. |
| ANDA 074300 | Lorazepam Injection USP, 2 mg/mL and 4 mg/mL | Do. |
| ANDA 074396 | Enflurane Inhalation , 99.9% | Piramal Critical Care, Inc., 3950 Schelden Circle, Bethlehem, PA 18017. |
| ANDA 074546 | Clozapine Tablets USP, 25 mg and 100 mg | Sandoz, Inc. |
| ANDA 074632 | Atracurium Besylate Injection, 10 mg/mL | Hospira, Inc. |
| ANDA 074851 | Levobunolol HCl Ophthalmic Solution USP, 0.25% | Alcon Laboratories, Inc. |
| ANDA 074927 | Etodolac Tablets USP, 400 mg | Lehigh Valley Technologies, Inc., 514 North 12th St., Allentown, PA 18102. |
| ANDA 075117 | Orapred (prednisolone sodium phosphate) Oral Solution, EQ 15 mg base/5 mL | Concordia Pharmaceuticals, Inc., c/o Mapi USA, Inc., 2343 Alexandria Dr., Suite 100, Lexington, KY 40504. |
| ANDA 075436 | Paclitaxel Injection USP, 6 mg/mL | Accord Healthcare Inc., 1009 Slater Rd., Suite 210-B, Durham, NC 27703. |
| ANDA 075721 | Leuprolide Acetate Injection, 1 mg/0.2 mL | Genzyme Corp., 500 Kendall St., Cambridge, MA 02142. |
| ANDA 075963 | Tramadol HCl Tablets, 50 mg | Ivax Pharmaceuticals Inc. |
| ANDA 076234 | Flavoxate HCl Tablets, 100 mg | Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. |
| ANDA 076296 | Vincristine Sulfate Injection USP, 1 mg/mL | Fresenius Kabi USA, LLC. |
| ANDA 076394 | Amiodarone HCl Injection, 50 mg/mL | Par Sterile Products, LLC, Morris Corporate Center 2, One Upper Pond Rd., Parsippany, NJ 07054. |
| ANDA 076401 | Vincristine Sulfate Injection USP, 1 mg/mL | Fresenius Kabi USA, LLC. |
| ANDA 076414 | Milrinone Lactate in 5% Dextrose Injection, EQ 20 mg base/100 mL | B. Braun Medical Inc. |
| ANDA 076563 | Diltiazem HCl Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, 360 mg, 420 mg | Nesher Pharmaceuticals (USA) LLC, 13910 St. Charles Rock Rd., Bridgeton, MO 63044. |
| ANDA 076699 | Parcopa (carbidopa and levodopa) Orally Disintegrating Tablets, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg | UCB, Inc., 1950 Lake Park Dr., Bldg. 2100, Smyrna, GA 30080. |
| ANDA 077275 | Didanosine Tablets for Oral Suspension USP, 100 mg, 150 mg, and 200 mg | Aurobindo Pharma Limited. |
| ANDA 077774 | Stavudine for Oral Solution USP, 1 mg/mL | Do. |
| ANDA 077887 | Carvedilol Tablets USP, 3.125 mg, 6.25 mg, 12.5 mg, 25 mg | Hikma Pharmaceuticals, c/o West-Ward Pharmaceuticals Corp., 401 Industrial Way West, Eatontown, NJ 07724. |
| ANDA 077968 | Alprazolam Extended-Release Tablets, 0.5 mg, 1 mg, 2 mg, and 3 mg | Impax Laboratories, Inc. |
| ANDA 077996 | Alprazolam Extended-Release Tablets, 0.5 mg, 1 mg, 2 mg, 3 mg | Do. |
| ANDA 078112 | Didanosine for Oral Solution USP, 10 mg/mL | Aurobindo Pharma Limited. |
| ANDA 078240 | Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg | Pliva Hrvatska d.o.o., Subsidiary of Teva Pharmaceutical Industries Ltd., 425 Privet Rd., Horsham, PA 19044. |
| ANDA 078254 | Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg | Northstar Healthcare Holdings, c/o Quality Regulatory Consultants, 1966 Anglers Cove, Vero Beach, FL 32963. |
| ANDA 078285 | Bicalutamide Tablets USP, 50 mg | Roxane Laboratories, Inc. |
| ANDA 078298 | Sumatriptan Succinate Tablets USP, EQ 25 mg base, EQ 50 mg base, EQ 100 mg base | Hikma Pharmaceuticals. |
| ANDA 078310 | Lamotrigine Tablets USP, 25 mg, 100 mg, 150 mg, and 200 mg | Pharmascience Inc., c/o Pharmascience Laboratories Inc., 295 Firetower Rd., Tonawanda, NY 14150. |
| ANDA 078334 | Granisol (granisetron HCl Oral Solution, 2 mg base/10mL | PediatRx, Inc., c/o Cardinal Health Regulatory Sciences, 7400 West 110th St., Commerce Plaza II, Suite 300, Overland Park, KS 66210. |
| ANDA 078374 | Metoclopramide Tablets USP, EQ 5 mg base and EQ 10 mg base | Northstar Healthcare Holdings. |
| ANDA 078408 | Vinorelbine Injection USP, EQ 10 mg base/mL | Sandoz Inc. |
| ANDA 078501 | Dronabinol Capsules USP, 2.5 mg, 5 mg, and 10 mg | Insys Therapeutics, Inc., 1333 South Spectrum Blvd., Suite 100, Chandler, AZ 85286. |
| ANDA 078577 | Levofloxacin Injection, EQ 750 mg/30 mL and EQ 500 mg/20 mL | Hospira Inc. |
| ANDA 078782 | Gabapentin Tablets USP, 600 mg and 800 mg | Hikma Pharmaceuticals. |
| ANDA 078808 | Granisetron HCl Injection USP, EQ 0.1 mg base/mL | Sandoz Inc. |
| ANDA 078812 | Oxaliplatin Injection USP, 50 mg/10 mL and 100 mg/20 mL | Do. |
| ANDA 078952 | Glimepiride Tablets USP, 1 mg, 2 mg, and 4 mg | Hikma Pharmaceuticals. |
| ANDA 079033 | Fomepizole Injection, 1.5 g/1.5 mL | Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103. |
| ANDA 080020 | Isopto Cetamide (sulfacetamide sodium) Ophthalmic Solution, 15% | Alcon Laboratories, Inc. |
| ANDA 080021 | Sulfacetamide Sodium Ophthalmic Ointment, 10% | Do. |
| ANDA 080229 | Naphcon Forte (naphazoline HCl) Ophthalmic Solution USP 0.1% | Do. |
| ANDA 080248 | Albalon (naphazoline HCl) Ophthalmic Solution USP, 0.1% | Allergan, Inc. |
| ANDA 080472 | Hytone (hydrocortisone) Cream, 1% and 2.5% | Valeant International (Barbados) SRL, c/o Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. |
| ANDA 080473 | Hytone (hydrocortisone) Lotion, 1% and 2.5% | Do. |
| ANDA 081043 | Prednisolone Sodium Phosphate Ophthalmic Solution USP, EQ 0.11% phosphate | Alcon Pharmaceuticals, Ltd. |
| ANDA 081044 | Prednisolone Sodium Phosphate Ophthalmic Solution USP, EQ 0.9% phosphate | Do. |
| ANDA 083205 | Orabase HCA (hydrocortisone acetate) Topical Paste, 0.5% | Colgate-Palmolive Co., 909 River Rd., P.O. Box 1343, Piscataway, NJ 08855-1343. |
| ANDA 083342 | Maxidex (dexamethasone sodium phosphate) Ophthalmic Ointment, EQ 0.05% phosphate | Alcon Laboratories, Inc. |
| ANDA 084645 | Chlordiazepoxide HCl Capsules USP, 25 mg | Upsher-Smith Laboratories, Inc. |
| ANDA 084927 | Methocarbamol Tablets USP, 500 mg | Impax Laboratories, Inc. |
| ANDA 084928 | Methocarbamol Tablets USP, 750 mg | Do. |
| ANDA 085000 | Chlordiazepoxide HCl Capsules USP, 10 mg | Hikma Pharmaceuticals. |
| ANDA 085014 | Chlordiazepoxide HCl Capsules USP, 5 mg | Do. |
| ANDA 085095 | Statobex-G (phendimetrazine tartrate) Tablets, 35 mg | Teva Pharmaceuticals USA, Inc. |
| ANDA 085294 | Chlordiazepoxide HCl Capsules USP, 25 mg | Hikma Pharmaceuticals. |
| ANDA 085380 | Butisol Sodium (butabarbital sodium) Oral Solution USP, 30 mg/5 mL | Meda Pharmaceuticals Inc., 265 Davidson Ave., Suite #4300, Somerset, NJ 08873. |
| ANDA 085734 | Ammonium Chloride Injection USP, 40 mEQ/100 mL | B. Braun Medical Inc. |
| ANDA 085981 | Hydrocortisone Acetate USP Micronized for Prescription Compounding, 100% | X-Gen Pharmaceuticals, Inc. |
| ANDA 085982 | Hydro-Rx (hydrocortisone) USP Micronized for Prescription Compounding, 100% | Do. |
| ANDA 085995 | Pediatric LTA Kit (lidocaine HCl) Topical Solution USP, 2% | Hospira, Inc. |
| ANDA 086535 | Acticort (hydrocortisone) Lotion USP, 1% | Baker Norton Pharmaceuticals Inc., 8800 N.W. 36 St., Miami, FL 33178-2404. |
| ANDA 086911 | Phentermine HCl Capsules USP, 30 mg | Teva Pharmaceuticals USA, Inc. |
| ANDA 087547 | Isopto Cetapred (sulfacetamide sodium and prednisolone acetate) Ophthalmic Ointment USP, 10%/0.25% | Alcon Laboratories, Inc. |
| ANDA 087771 | Cetapred (sulfacetamide sodium and prednisolone acetate) Ophthalmic Ointment USP, 10%/0.25% | Do. |
| ANDA 087907 | Epinephrine Inhalation Aerosol USP, 0.2 mg/inhalation) | Armstrong Pharmaceuticals, Inc., 25 John Rd., Canton MA 02021. |
| ANDA 088613 | Phentermine HCl Capsules USP, 30 mg | Teva Pharmaceuticals USA, Inc. |
| ANDA 088614 | Phentermine HCl Capsules USP, 30 mg | Do. |
| ANDA 088630 | Pseudoephedrine HCl and Triprolidine HCl Tablets, 60 mg/2.5 mg | Do. |
| ANDA 088631 | Butabarbital Sodium Tablets, 30 mg | Do. |
| ANDA 088632 | Butabarbital Sodium Tablets, 15 mg | Do. |
| ANDA 088797 | Phentermine HCl Capsules USP, 30 mg | USL Pharma Inc., 301 South Cherokee St., Denver, CO 80223 |
| ANDA 088910 | Phentermine HCl Tablets USP, 37.5 mg | Do. |
| ANDA 088917 | Phentermine HCl Tablets USP, 37.5 | Do. |
| ANDA 088999 | Dipyridamole Tablets USP, 25 mg | Glenmark Generics Limited, c/o Glenmark Generics Inc., USA, 750 Corporate Dr., Mahwah, NJ 07430. |
| ANDA 089000 | Dipyridamole Tablets USP, 50 mg | Do. |
| ANDA 089001 | Dipyridamole Tablets USP, 75 mg | Do. |
| ANDA 089068 | Sulfacetamide Sodium Ophthalmic Solution, 30% | Alcon Pharmaceuticals, Ltd. |
| ANDA 089172 | Tropicamide Ophthalmic Solution, 1% | Do. |
| ANDA 089422 | Imipramine HCl Tablets USP, 10 mg | Par Pharmaceutical Inc., One Ram Ridge Rd., Spring Valley, NY 10977. |
| ANDA 089440 | Hydrocortisone Acetate and Pramoxine HCl Topical Aerosol, 1%/1% | Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL 35811. |
| ANDA 089497 | Imipramine HCl Tablets USP, 25 mg | Par Pharmaceutical Inc. |
| ANDA 089628 | Leucovorin Calcium for Injection, EQ 50 mg base/vial | Pharmachemie USA Inc., 323 Davis St., Northborough, MA 01532. |
| ANDA 089681 | Bromfed-DM (brompheniramine maleate, dextromethorphan hydrobromide, and pseudoephedrine HCl) Syrup, 2 mg/5 mL; 10mg/5 mL; 30mg/5 mL | Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc., 6451 Main St., Morton Grove, IL 60053. |
| ANDA 089915 | Leucovorin Calcium for Injection, EQ 100 mg base/vial | Pharmachemie USA Inc. |
| ANDA 090098 | Tretinoin Cream USP, 0.0375% | Allergan Sales, LLC. |
| ANDA 090137 | Irinotecan HCl Injection, 40 mg/2 mL and 100 mg/5 mL | Sandoz Inc. |
| ANDA 090190 | Pramipexole Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg | Do. |
| ANDA 090220 | Adenosine Injection USP, 3 mg/mL | Wockhardt Limited, c/o Wockhardt USA LLC, 20 Waterview Blvd., 3rd Floor, Parsippany, NJ 07054. |
| ANDA 090300 | Children's Cetirizine HCl Allergy and Hives Relief Oral Solution OTC, 5 mg/5 mL | Cypress Pharmaceutical, Inc., 10 North Park Place, Suite 210, Morristown, NJ 07960. |
| ANDA 090751 | Cetirizine HCl Oral Solution USP, 5 mg/5 mL | Aurobindo Pharma Limited. |
| ANDA 090985 | Octreotide Acetate Preservative Free Injection EQ 0.05 mg base/mL, EQ 0.1 mg base/mL, and EQ 0.5 mg base/mL | Wockhardt Limited. |
| ANDA 090986 | Octreotide Acetate Injection EQ 0.2 mg base/mL and EQ 1 mg base/mL | Do. |
| ANDA 091068 | Ceftriaxone for Injection USP, EQ 10 g base/vial | Agila Specialties Private Limited, c/o Agila Specialties Inc., 201 South Main St., Suite 3, Lambertville, NJ 08530. |
| ANDA 091185 | Topiramate Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg | Hikma Pharmaceuticals. |
| ANDA 091293 | Idarubicin HCl Injection, 1 mg/mL | Sandoz Inc. |
| ANDA 091299 | Fluorouracil Injection USP, 2.5 g/50 mL and 5 g/100 mL | Do. |
| NDA 200045 | Amturnide (aliskiren hemifumarate, amlodipine, andhydrochlorothiazide) Tablets | Novartis Pharmaceuticals Corp. |
| ANDA 200146 | Doxorubicin HCl Injection USP, 2 mg/mL | Sandoz Inc. |
| NDA 200199 | Topotecan Injection, EQ 1 mg base/mL, EQ 3 mg base/3 mL, and EQ 4 mg base/4 mL | Do. |
| ANDA 201211 | Bromfenac Sodium Ophthalmic Solution, EQ 0.09% acid | Coastal Pharmaceuticals, 1240 Sugg Parkway, Greenville, NC 27834. |
| NDA 201917 | Incivek (telaprevir) Tablets, 375 mg | Vertex Pharmaceuticals, Inc., 50 Northern Ave., Boston, MA 02210. |
| NDA 202088 | Suprenza (phentermine HCl) Orally Disintegrating Tablets, 15 mg, 30 mg, and 37.5 mg | Citius Pharmaceuticals, LLC, 11 Commerce Dr., First Floor, Cranford, NJ 07016. |
| ANDA 202209 | Tretinoin Cream USP, 0.075% | Allergan Sales, LLC. |
| NDA 202513 | Gelnique (oxybutynin) Gel, 3% | Do. |
| NDA 203595 | Suclear (magnesium sufate, polyethylene glycol 3350, potassium chloride, potassium sulfate, sodium bicarbonate, sodium chloride, and sodium sulfate) Oral Solution | Braintree Laboratories, Inc. |
| NDA 204508 | Clinolipid 20% (olive oil and soybean oil) USP, 16%/4% | Baxter Healthcare Corp. |
| NDA 206510 | Dutrebis (lamivudine and raltegravir potassium) Tablets, 150 mg/EQ 300 mg base | Merck Sharp & Dohme Corp. |
Therefore, under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that are in inventory on the date that this notice becomes effective (see the DATES section) may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12908 Filed 6-20-17; 8:45 am]
BILLING CODE 4164-01-P