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[Docket No. FDA-2017-N-3203] Wyeth Pharmaceutical

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[Docket No. FDA-2017-N-3203] Wyeth Pharmaceutical This document is scheduled to be published in the Federal Register on 06/21/2017 and available online at https://federalregister.gov/d/2017-12908, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-3203] Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. 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. 2 Table 1 Application No. Drug Applicant NDA 005897 Folvite (folic acid) Injection, 5 milligrams Wyeth Pharmaceuticals Inc., Subsidiary of (mg)/milliliter (mL) 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 Shire Development Inc., 725 Chesterbrook mg Blvd., Wayne, PA 19087 NDA 008126 Cortisone Acetate (cortisone acetate) Tablets, 5 Pharmacia & Upjohn Co., Subsidiary of mg, 10 mg, and 25 mg; and Injection, 25 Pfizer Inc., 235 East 42nd St., New mg/mL York, NY 10017 NDA 008732 Pro-Banthine (propantheline bromide) Tablets, Shire Development Inc. 7.5 mg and 15 mg 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)) Sanofi-Aventis US LLC, 55 Corporate Tablets USP 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) Pharmacia & Upjohn Co. Topical Ointment, 0.25% and 1% NDA 013935 Herplex (idoxuridine) Ophthalmic Solution, Allergan, Inc., 2525 Dupont Dr., P.O. Box 0.1% 19534, Irvine, CA 92623-9534 NDA 013993 Chromitope Sodium (sodium chromate Cr 51) Bracco Diagnostics Inc., 259 Prospect Injection USP, 2 millicuries (mCi)/vial and Plains Rd., Bldg. H, Monroe 200 microcuries (uCi)/mL 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, Sanofi-Aventis US LLC, c/o Sanofi US 500 mg, and 1 gram (g) Services Inc., 55 Corporate Dr., Bridgewater, NJ 08807 NDA 014295 Conray 400 (iothalamate sodium) Injection Mallinckrodt Inc., 675 McDonnell Blvd., USP, 66.8% Hazelwood, MO 63042 NDA 016089 Rubratope-57 (cyanocobalamin CO-57) Bracco Diagnostics Inc. Capsules, 0.5-1 uCi and Rubratope-57 Kit (cobalt chloride CO-57, cyanocobalamin, cyanocobalamin CO-57, intrinsic factor) NDA 016672 Ovral (ethinyl estradiol and norgestrel) Tablets, Wyeth Pharmaceuticals Inc. 0.05 mg/0.5 mg NDA 016692 M/6 Sodium Lactate (sodium lactate) Injection Baxter Healthcare Corp. USP, 1.87 g/100 mL NDA 016696 Dextrose 10% and Sodium Chloride 0.9% Do. Injection USP in Plastic Container 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) GD Searle LLC, Subsidiary of Pfizer Inc., Tablets 235 East 42nd St., New York, NY 10017 3 Application No. Drug Applicant NDA 016806 Ovral-28 (ethinyl estradiol and norgestrel) Wyeth Pharmaceuticals Inc. Tablets, 0.05 mg/0.5 mg 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 ) Warner Chilcott Co., LLC, Union Street Tablets USP, 0.05 mg/1 mg Road, 195 km 1.1, Fajrado, Puerto Rico 00738 NDA 017670 Sodium Chloride 0.45% in Plastic Container, Hospira, Inc. 275 North Field Dr., Lake Irrigation Forest, IL 60045 NDA 017756 Tylenol (acetaminophen) Suppositories, 120 mg Johnson & Johnson Consumer Inc., and 650 mg McNeil Consumer Healthcare Division, 7050 Camp Hill Rd., Fort Washington, PA 19034 NDA 017748 Noriday 1+50 (mestranol and norethindrone) GD Searle LLC Tablets NDA 018031 Inderide (propranolol HCl and Wyeth Pharmaceuticals Inc. hydrochlorothiazide) Tablets, 40 mg/25 mg and 80 mg/25 mg NDA 018039 Loxitane IM (loxapine HCl) Injection, Actavis Laboratories UT, Inc., Subsidiary Equivalent to (EQ) 50 mg base/mL of Teva Pharmaceuticals USA, Inc.425 Privet Road, Horsham, PA 19044 NDA 018104 Hylorel (guanadrel sulfate) Tablets, 10 mg and Pharmacia and Upjohn Co. 25 mg NDA 018239 Propine (dipivefrin HCl) Ophthalmic Solution Allergan, Inc. USP, 0.1% NDA 018254 Ringer’s and Dextrose 5% (calcium chloride, Hospira Inc. dextrose, potassium chloride, sodium chloride) Injection USP (in Plastic Container) NDA 018353 Flagyl I.V. (metronidazole HCl) for Injection, GD Searle LLC EQ 500 mg base/vial NDA 018388 Lidocaine HCl in Dextrose 5% in Plastic Hospira, Inc. Container Injection NDA 018404 0.25% Acetic Acid Irrigation Solution Do. NDA 018406 PhysioSol (magnesium chloride, potassium Do. chloride, sodium acetate, sodium chloride, sodium gluconate) Irrigation Solution NDA 018460 Dialyte (Peritoneal Dialysis Solution) Pattern B. Braun Medical Inc. LM (calcium chloride, dextrose, magnesium chloride, sodium acetate, sodium chloride) with Dextrose 4 Application No. Drug Applicant NDA 018465 Soyacal (soybean oil) Injection, 10% Grifols Biologicals Inc., 5555 Valley Blvd., Los Angeles, CA 90032 NDA 018509 Baros (sodium bicarbonate, tartaric acid) Mallinckrodt Inc. Effervescent Granules, 460 mg/g; 420 mg/g) 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) B. Braun Medical Inc. (calcium chloride, dextrose, magnesium chloride, sodium acetate, sodium chloride) with Dextrose NDA 018887 Intal (cromolyn sodium) Metered Dose Inhaler, King Pharmaceuticals Inc., Subsidiary of 0.8 mg/inhalation 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) Do. Injection NDA 018997 Liposyn II 10% (safflower oil and soybean oil) Do. Injection 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 EMD Serono, Inc., One Technology Pl., Injection, 75 international units (IU)/ampule Rockland, MA 02370 and 150 IU/ampule, and Metrodin (urofollitropin) for Intramuscular Injection, 75 IU)/ampule and 150 IU/ampule 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, Janssen Pharmaceuticals, Inc., 1000 U.S. 80 mg Highway 202, Raritan, NJ 08869 NDA 019643 Mevacor (lovastatin) Tablets, 10 mg, 20 mg, Merck Sharp & Dohme Corp. and 40 mg NDA 019660 Tilade (nedocromil sodium) Metered Dose King Pharmaceuticals Inc. Inhaler, 1.75 mg/inhalation NDA 019793 Pharmaseal Scrub Care (chlorhexidine CareFusion 2200, Inc., 75 North Fairway gluconate) Sponge, 4% Dr., Vernon Hills, IL 60061 NDA 019802 Heparin Sodium in
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