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. |
Start Printed Page 28324 |
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. |
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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. |
Start Printed Page 28326 |
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. |
Start Printed Page 28327 |
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. |
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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. |
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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. |