Merck & Co., Inc., et al.; Withdrawal of Approval of 65 New Drug Applications and 52 Abbreviated New Drug Applications, 34940-34944 [E6-9440]

Download as PDF 34940 Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices and resultant under-utilization; Form Number: CMS–R–52 (OMB#: 0938– 0386); Frequency: Recordkeeping and Reporting—Annually; Affected Public: Business or other for-profit and Federal government; Number of Respondents: 4,757; Total Annual Responses: 4,757; Total Annual Hours: 160,702. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995, or Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Application No. Washington, DC 20503. Fax Number: (202) 395–6974. Dated: June 9, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6–9479 Filed 6–15–06; 8:45 am] BILLING CODE 4120–01–P approval of 65 new drug applications (NDAs) and 52 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0222] Merck & Co., Inc., et al.; Withdrawal of Approval of 65 New Drug Applications and 52 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing Effective June 16, 2006. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research (HFD–7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594– 2041. The holders of the applications listed in the table in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications. The applicants have also, by their requests, waived their opportunity for a hearing. SUPPLEMENTARY INFORMATION: Drug Applicant Vitamin B6 (pyridoxine hydrochloride (HCl)) Merck & Co., Inc., 770 Sumneytown Pike, P.O. Box 4, BLA–20, West Point, PA 19486–0004 NDA 5–521 Heparin Sodium Injection USP Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 NDA 5–657 Tubocurarine Chloride Injection USP Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543– 4500 NDA 5–794 Sultrin Triple Sulfa Cream and Triple Sulfa Tablets Ortho-McNeil Pharmaceutical, Inc., 1000 U.S. Highway 202, P.O. Box 300, Raritan, NJ 08869–0602 NDA 6–012 Folvron (folic acid and iron) Lederle Laboratories, 401 North Middleton Rd., Pearl River, NY 10965 NDA 7–149 Rubramin (cyanocobalamin) Tablets and Capsules Bristol-Myers Squibb Co. NDA 7–504 Acthar (corticotropin for injection) Aventis Pharmaceuticals, Inc., 200 Crossing Blvd., BX 2–309E, Bridgewater, NJ 08807 NDA 7–794 Neothylline (dyphylline) Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454 NDA 9–176 Cortril (hydrocortisone) Topical Ointment Pfizer Global Pharmaceuticals, 235 East 42nd St., New York, NY 10017 NDA 10–028 Equanil (meprobamate) Tablets Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101–8299 NDA 10–093 Biphetamine (dextroamphetamine and amphetamine) Capsules Celltech Pharmaceuticals, Inc., 755 Jefferson Rd., P.O. Box 31710, Rochester, NY 14603 NDA 10–513 Ketonil (amino acids and electrolytes) Merck & Co., Inc. NDA 10–787 wwhite on PROD1PC61 with NOTICES NDA 1–645 Iron Dextran Injection Aventis Pharmaceuticals, Inc. NDA 10–799 Dimetane (brompheniramine maleate) Tablets and Extendtabs Wyeth Consumer Healthcare, 5 Giralda Farms, Madison, NJ 07940 NDA 11–340 Cerumenex (triethanolamine polypeptide oleate-condensate), 10% The Purdue Frederick Co., 1 Stamford Forum, Stamford, CT 06901–3431 VerDate Aug<31>2005 18:25 Jun 15, 2006 Jkt 208001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\16JNN1.SGM 16JNN1 Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices Application No. Drug 34941 Applicant Aristocort (triamcinolone diacetate) Syrup Astellas Pharma US, Inc., 3 Parkway North, Deerfield, IL 60015– 2548 NDA 11–984 Decadron Phosphate (dexamethasone sodium phosphate) Sterile Ophthalmic Solution Merck & Co., Inc. NDA 12–122 Glucagon (glucagon HCl) for Injection Eli Lilly & Co. NDA 12–281 Robaxisal (methocarbamol USP and aspirin USP) Tablets A.H. Robins Co., c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101–8299 NDA 12–649 Periactin (cyproheptadine HCl) Merck & Co., Inc. NDA 12–703 Elavil (amitriptyline HCl) Tablets AstraZeneca Pharmaceuticals, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803–8355 NDA 12–704 Elavil (amitriptyline HCl) Injection Do. NDA 13–220 Periactin (cyproheptadine HCl) Syrup, 2 milligrams (mg)/ 5 milliliters (mL) Merck & Co., Inc. NDA 13–400 Aldomet (methyldopa) Tablets Do. NDA 13–401 Aldomet (methyldopate HCl) Injection, 50 mg/mL Do. NDA 13–413 Dexacort Phosphate (dexamethasone sodium phosphate) in Respihaler Celltech Pharmaceuticals, Inc. NDA 16–016 Aldoclor–150 and -250 (methyldopa and chlorothiazide) Tablets, 250 mg/150 mg and 250 mg/250 mg Merck & Co., Inc. NDA 16–030 Bayer 8 Hour Aspirin and Measurin Aspirin (aspirin extended-release tablets), 650 mg Bayer Healthcare, LLC, 36 Columbia Rd., P.O. Box 1910, Morristown, NJ 07962–1910 NDA 16–099 Atromid-S (clofibrate) Capsules Wyeth Pharmaceuticals NDA 16–745 Jergens Antibacterial Deodorant (triclocarban, 1%) Soap Kao Brands Co., 2535 Springs Grove Ave., Cincinnati, OH 45214–1773 NDA 16–888 Selsun Blue (selenium sulfide) Cream/Shampoo, 1% Abbott Laboratories, 625 Cleveland Ave., Columbus, OH 43215– 1724 NDA 17–569 Renoquid (sulfacytine) Tablets Glenwood LLC, 111 Cedar Lane, Englewood, NJ 07631 NDA 17–573 Vanceril (beclomethasone dipropionate) Inhalation Aerosol Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033 NDA 17–659 Alupent (metaproterenol sulfate) Inhalation Solution, 5% Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877–0368 NDA 17–781 Diprosone (betamethasone dipropionate) Lotion Schering Corp. NDA 17–820 Dobutrex (dobutamine HCl) Sterile Injection Eli Lilly & Co. ANDA 18–023 Lactated Ringer’s Injection USP B. Braun Medical, Inc., 2525 McGaw Ave., P.O. Box 19791, Irvine, CA 92623–9791 ANDA 18–026 5% Dextrose and 0.9% Sodium Chloride (NaCl) Injection Do. ANDA 18–046 10% Dextrose Injection USP Do. ANDA 18–047 10% Dextrose and 0.9% NaCl Injection USP Do. ANDA 18–184 0.45% NaCl Injection USP Do. ANDA 18–186 1/6 Molar Sodium Lactate Injection USP in Plastic Container Do. ANDA 18–197 wwhite on PROD1PC61 with NOTICES NDA 11–960 Ibuprofen Tablets BASF Corp., 8800 Line Ave., Shreveport, LA 71106 ANDA 18–252 Isolyte S (multi-electrolyte injection) Injection B. Braun Medical, Inc. ANDA 18–256 5% Dextrose in Ringer’s Injection Do. NDA 18–257 Tonocard (tocainide HCl) Tablets, 400 mg and 600 mg AstraZeneca Pharmaceuticals VerDate Aug<31>2005 18:25 Jun 15, 2006 Jkt 208001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\16JNN1.SGM 16JNN1 34942 Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices Drug ANDA 18–274 Isolyte S (multi-electrolyte injection) with 5% Dextrose in Plastic Container B. Braun Medical, Inc. NDA 18–389 Aldomet (methyldopa) Oral Suspension, 250 mg/5 mL Merck & Co., Inc. NDA 18–682 TZ–3 (1% tioconazole) Dermal Cream Pfizer, Inc., 235 East 42nd St., New York, NY 10017 NDA 18–686 Normodyne (labetalol HCl USP) Injection, 5 mg/mL Schering Corp. NDA 18–687 Normodyne (labetalol HCl USP) Tablets Do. ANDA 18–721 Ringer’s Injection USP B. Braun Medical, Inc. NDA 18–754 Orudis (ketoprofen) Capsules, 25 mg, 50 mg, and 75 mg Wyeth Pharmaceuticals NDA 18–792 Neopham (amino acids) Injection Hospira, Inc., 275 North Field Dr., Dept. 389, Bldg. 2, Lake Forest, IL 60045 NDA 18–901 Aminess (essential amino acids injection with histidine) Do. NDA 18–911 Heparin Sodium in 5% Dextrose Injection and Heparin Sodium in NaCl Injection Do. NDA 19–083 Theophylline and 5% Dextrose Injection B. Braun Medical, Inc. NDA 19–107 Protropin (somatrem) for Injection Genentech, Inc., 1 DNA Way MSι242, South San Francisco, CA 94080–4990 ANDA 19–138 Alphatrex (betamethasone dipropionate cream USP) 0.05% Savage Laboratories, 60 Baylis Rd., Melville, NY 11747 ANDA 19–143 Alphatrex (betamethasone dipropionate ointment USP) 0.05% Do. NDA 19–383 Proventil (albuterol sulfate extended-release tablets USP) Repetabs Schering Corp. NDA 19–401 Pseudo–12 Suspension (pseudoephedrine polistirex extended-release suspension) Celltech Pharmaceuticals, Inc. NDA 19–523 Cysteine HCl Injection USP, 7.25% Hospira, Inc. NDA 19–589 Vancenase AQ (beclomethasone dipropionate) Nasal Spray Schering Corp. NDA 19–621 Ventolin (albuterol sulfate) Syrup GlaxoSmithKline Pharmaceuticals, 5 More Dr., P.O. Box 13358, Research Triangle Park, NC 27709 NDA 20–035 Ergamisol (levamisole HCl) Tablets Johnson & Johnson Pharmaceutical Research and Development, LLC, c/o Janssen Pharmaceutical Products, LP, 1125 Trenton-Harbourton Rd., K1–02B, Titusville, NJ 08560–0200 NDA 20–176 VitaPed (multivitamins) Hospira, Inc. NDA 20–338 Differin (adapalene) Solution, 0.1% Galderma Laboratories, LP, 14501 North Freeway, Fort Worth, TX 76177 NDA 20–759 Trovan (trovafloxacin mesylate) Tablets, 100 mg and 200 mg Pfizer, Inc. NDA 20–760 Trovan (alatrofloxacin mesylate) Injection Do. NDA 20–847 Esclim (estradiol extended-release film) Transdermal System Women First Healthcare, Inc., 380 Lexington Ave., New York, NY 10168 NDA 20–962 wwhite on PROD1PC61 with NOTICES Application No. Emla (2.5% lidocaine and 2.5% prilocaine) Anesthetic Disc AstraZeneca Pharmaceuticals ANDA 40–023 Adrucil (fluorouracil injection USP), 50 mg/mL Sicor Pharmaceuticals, Inc., 19 Hughes, Irvine, CA 92618 ANDA 40–147 Leucovorin Calcium Injection USP, 10 mg (base)/mL Hospira, Inc. NDA 50–039 Garamycin (gentamicin sulfate) Ophthalmic Solution Schering Corp. VerDate Aug<31>2005 18:25 Jun 15, 2006 Jkt 208001 PO 00000 Applicant Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\16JNN1.SGM 16JNN1 Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices Application No. Drug 34943 Applicant Chloroptic (chloramphenicol ophthalmic solution USP), 0.5% Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623–9534 NDA 50–322 Neodecadron (neomycin sulfate and dexamethasone sodium phosphate) Sterile Ophthalmic Solution Merck & Co., Inc. NDA 50–368 Ilotycin (erythromycin) Ophthalmic Ointment Eli Lilly & Co. NDA 50–571 CefMax (cefmenoxime HCl) Injection TAP Pharmaceutical Products, Inc., 675 North Field Dr., Lake Forest, IL 60045 NDA 50–648 Clindamycin Phosphate Injection in 5% Dextrose Baxter Healthcare Corp., Route 120 & Wilson Rd., Round Lake, IL 60073 ANDA 60–429 Sumycin Capsules (tetracycline HCl capsules USP) Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543–4500 ANDA 62–480 Gentacidin Solution (gentamicin sulfate ophthalmic solution USP) Novartis Pharmaceuticals Corp., 1 Health Plaza, Bldg. 118, East Hanover, NJ 07936–1080 ANDA 62–597 Mytrex (nystatin and triamcinolone acetonide cream USP) 100,000 units/gram (g) and 1 mg/g Savage Laboratories ANDA 62–601 Mytrex (nystatin and triamcinolone acetonide ointment USP) 100,000 units/g and 1 mg/g Do. ANDA 62–750 Pipracil (piperacillin for injection), 2 g, 3 g, and 4 g Wyeth Pharmaceuticals, Inc. ANDA 63–186 Cephalexin Capsules USP, 250 mg and 500 mg Apothecon, c/o Bristol-Myers Squibb Co. ANDA 64–084 Sterile Bleomycin Sulfate for Injection USP, 15 and 30 units/vial Sicor Pharmaceuticals, Inc. ANDA 70–083 Ibuprofen Tablets USP, 400 mg BASF Corp. ANDA 70–099 Ibuprofen Tablets USP, 600 mg Do. ANDA 70–273 Alphatrex (betamethasone dipropionate lotion USP), 0.05% Savage Laboratories ANDA 70–745 Ibuprofen Tablets USP, 800 mg BASF Corp. ANDA 72–621 Acetylcysteine Solution USP, 10% Roxane Laboratories, Inc., P.O. Box 16532, Columbus, OH 43216 ANDA 72–622 Acetylcysteine Solution USP, 20% Do. ANDA 72–995 Metoclopramide HCl Oral Solution, 10 mg/mL Do. ANDA 73–562 Diflunisal Tablets USP, 250 mg Do. ANDA 73–563 Diflunisal Tablets USP, 500 mg Do. ANDA 74–166 Toposar (etoposide injection USP), 20 mg/mL Sicor Pharmaceuticals, Inc. ANDA 74–541 Cimetidine HCl Oral Solution, 30 mg/5 mL Roxane Laboratories, Inc. ANDA 74–663 Acyclovir Sodium for Injection USP, 500 mg base/vial and 1 g base/vial Hospira, Inc. ANDA 75–179 Nabumetone Tablets Copley Pharmaceutical, Inc., 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454 ANDA 75–875 Carbamazepine Oral Suspension USP, 100 mg/5 mL Taro Pharmaceutical Industries, Ltd., c/o Taro Pharmaceuticals, U.S. Agent, 5 Skyline Dr., Hawthorne, NY 10532 ANDA 80–643 Diphenhydramine HCl Elixir USP, 25 mg/10 mL Roxane Laboratories, Inc. ANDA 81–225 wwhite on PROD1PC61 with NOTICES NDA 50–091 Adrucil (etopside injection USP), 50 mg/mL Sicor Pharmaceuticals, Inc. ANDA 83–261 Pentobarbital Sodium Injection USP Wyeth Pharmaceuticals ANDA 83–383 Diucardin (hydroflumethiazide tablets USP) Tablets, 50 mg Do. VerDate Aug<31>2005 18:25 Jun 15, 2006 Jkt 208001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\16JNN1.SGM 16JNN1 34944 Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices Application No. Drug Applicant ANDA 84–015 Bleph–10 (sulfacetamide sodium ophthalmic ointment USP) Ophthalmic Ointment, 10% Allergan, Inc. ANDA 84–514 Dilor (dyphylline tablets USP), 200 mg Savage Laboratories ANDA 84–751 Dilor–400 (dyphylline tablets USP), 400 mg Do. ANDA 85–035 Diphenoxylate HCl and Atropine Sulfate Tablets USP, 2.5 mg and 0.025 mg R & S Pharma, LLC, 8407 Austin Tracy Rd., Fountain Run, KY 42133 ANDA 85–961 Methocarbamol Tablets USP, 500 mg Clonmel Healthcare Ltd., c/o STADA Pharmaceuticals, Inc., U.S. Agent, 5 Cedar Brook Dr., Cranbury, NJ 08512 ANDA 85–963 Methocarbomal Tablets USP, 750 mg Do. ANDA 86–899 Isoetharine HCl Inhalation Solution USP, 1% Roxane Laboratories, Inc. ANDA 87–450 Chlorthalidone Tablets USP, 50 mg Clonmel Healthcare Ltd. ANDA 87–451 Chlorthalidone Tablets USP, 25 mg Do. ANDA 87–500 Aminophylline Tablets USP, 100 mg Roxane Laboratories, Inc. ANDA 87–501 Aminophylline Tablets USP, 200 mg Do. ANDA 88–253 T-Phyl (theophylline) Extended-Release Tablets, 200 mg The Purdue Frederick Co. Therefore, under section 505(e), of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)), and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner of Food and Drugs, approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective June 16, 2006. Dated: May 23, 2006. Douglas C. Throckmorton, Deputy Director, Center for Drug Evaluation and Research. [FR Doc. E6–9440 Filed 6–15–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003E–0254] Determination of Regulatory Review Period for Purposes of Patent Extension; INSPRA AGENCY: Food and Drug Administration, HHS. wwhite on PROD1PC61 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for INSPRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, VerDate Aug<31>2005 18:25 Jun 15, 2006 Jkt 208001 Department of Commerce, for the extension of a patent that claims that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD–7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594–2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 submission of an application to market the human drug product and continues until FDA grants permission to market the product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted, as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product INSPRA (eplerenone). INSPRA is indicated for the treatment of hypertension. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for INSPRA (U.S. Patent No. 4,559,332) from Novartis Corp., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated June 16, 2003, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of INSPRA represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for E:\FR\FM\16JNN1.SGM 16JNN1

Agencies

[Federal Register Volume 71, Number 116 (Friday, June 16, 2006)]
[Notices]
[Pages 34940-34944]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9440]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0222]


Merck & Co., Inc., et al.; Withdrawal of Approval of 65 New Drug 
Applications and 52 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 65 new drug applications (NDAs) and 52 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 June 16, 2006.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in 
the table in this document have informed FDA that these drug products 
are no longer marketed and have requested that FDA withdraw approval of 
the applications. The applicants have also, by their requests, waived 
their opportunity for a hearing.

------------------------------------------------------------------------
 Application
     No.                  Drug                       Applicant
------------------------------------------------------------------------
NDA 1-645      Vitamin B6 (pyridoxine      Merck & Co., Inc., 770
                hydrochloride (HCl))        Sumneytown Pike, P.O. Box 4,
                                            BLA-20, West Point, PA 19486-
                                            0004
------------------------------------------------------------------------
NDA 5-521      Heparin Sodium Injection    Eli Lilly and Co., Lilly
                USP                         Corporate Center,
                                            Indianapolis, IN 46285
------------------------------------------------------------------------
NDA 5-657      Tubocurarine Chloride       Bristol-Myers Squibb Co.,
                Injection USP               P.O. Box 4500, Princeton, NJ
                                            08543-4500
------------------------------------------------------------------------
NDA 5-794      Sultrin Triple Sulfa Cream  Ortho-McNeil Pharmaceutical,
                and Triple Sulfa Tablets    Inc., 1000 U.S. Highway 202,
                                            P.O. Box 300, Raritan, NJ
                                            08869-0602
------------------------------------------------------------------------
NDA 6-012      Folvron (folic acid and     Lederle Laboratories, 401
                iron)                       North Middleton Rd., Pearl
                                            River, NY 10965
------------------------------------------------------------------------
NDA 7-149      Rubramin (cyanocobalamin)   Bristol-Myers Squibb Co.
                Tablets and Capsules
------------------------------------------------------------------------
NDA 7-504      Acthar (corticotropin for   Aventis Pharmaceuticals,
                injection)                  Inc., 200 Crossing Blvd., BX
                                            2-309E, Bridgewater, NJ
                                            08807
------------------------------------------------------------------------
NDA 7-794      Neothylline (dyphylline)    Teva Pharmaceuticals USA,
                                            1090 Horsham Rd., P.O. Box
                                            1090, North Wales, PA 19454
------------------------------------------------------------------------
NDA 9-176      Cortril (hydrocortisone)    Pfizer Global
                Topical Ointment            Pharmaceuticals, 235 East
                                            42nd St., New York, NY 10017
------------------------------------------------------------------------
NDA 10-028     Equanil (meprobamate)       Wyeth Pharmaceuticals, P.O.
                Tablets                     Box 8299, Philadelphia, PA
                                            19101-8299
------------------------------------------------------------------------
NDA 10-093     Biphetamine                 Celltech Pharmaceuticals,
                (dextroamphetamine and      Inc., 755 Jefferson Rd.,
                amphetamine) Capsules       P.O. Box 31710, Rochester,
                                            NY 14603
------------------------------------------------------------------------
NDA 10-513     Ketonil (amino acids and    Merck & Co., Inc.
                electrolytes)
------------------------------------------------------------------------
NDA 10-787     Iron Dextran Injection      Aventis Pharmaceuticals, Inc.
------------------------------------------------------------------------
NDA 10-799     Dimetane (brompheniramine   Wyeth Consumer Healthcare, 5
                maleate) Tablets and        Giralda Farms, Madison, NJ
                Extendtabs                  07940
------------------------------------------------------------------------
NDA 11-340     Cerumenex (triethanolamine  The Purdue Frederick Co., 1
                polypeptide oleate-         Stamford Forum, Stamford, CT
                condensate), 10%            06901-3431
------------------------------------------------------------------------

[[Page 34941]]

 
NDA 11-960     Aristocort (triamcinolone   Astellas Pharma US, Inc., 3
                diacetate) Syrup            Parkway North, Deerfield, IL
                                            60015-2548
------------------------------------------------------------------------
NDA 11-984     Decadron Phosphate          Merck & Co., Inc.
                (dexamethasone sodium
                phosphate) Sterile
                Ophthalmic Solution
------------------------------------------------------------------------
NDA 12-122     Glucagon (glucagon HCl)     Eli Lilly & Co.
                for Injection
------------------------------------------------------------------------
NDA 12-281     Robaxisal (methocarbamol    A.H. Robins Co., c/o Wyeth
                USP and aspirin USP)        Pharmaceuticals, P.O. Box
                Tablets                     8299, Philadelphia, PA 19101-
                                            8299
------------------------------------------------------------------------
NDA 12-649     Periactin (cyproheptadine   Merck & Co., Inc.
                HCl)
------------------------------------------------------------------------
NDA 12-703     Elavil (amitriptyline HCl)  AstraZeneca Pharmaceuticals,
                Tablets                     1800 Concord Pike, P.O. Box
                                            8355, Wilmington, DE 19803-
                                            8355
------------------------------------------------------------------------
NDA 12-704     Elavil (amitriptyline HCl)  Do.
                Injection
------------------------------------------------------------------------
NDA 13-220     Periactin (cyproheptadine   Merck & Co., Inc.
                HCl) Syrup, 2 milligrams
                (mg)/5 milliliters (mL)
------------------------------------------------------------------------
NDA 13-400     Aldomet (methyldopa)        Do.
                Tablets
------------------------------------------------------------------------
NDA 13-401     Aldomet (methyldopate HCl)  Do.
                Injection, 50 mg/mL
------------------------------------------------------------------------
NDA 13-413     Dexacort Phosphate          Celltech Pharmaceuticals,
                (dexamethasone sodium       Inc.
                phosphate) in Respihaler
------------------------------------------------------------------------
NDA 16-016     Aldoclor-150 and -250       Merck & Co., Inc.
                (methyldopa and
                chlorothiazide) Tablets,
                250 mg/150 mg and 250 mg/
                250 mg
------------------------------------------------------------------------
NDA 16-030     Bayer 8 Hour Aspirin and    Bayer Healthcare, LLC, 36
                Measurin Aspirin (aspirin   Columbia Rd., P.O. Box 1910,
                extended-release            Morristown, NJ 07962-1910
                tablets), 650 mg
------------------------------------------------------------------------
NDA 16-099     Atromid-S (clofibrate)      Wyeth Pharmaceuticals
                Capsules
------------------------------------------------------------------------
NDA 16-745     Jergens Antibacterial       Kao Brands Co., 2535 Springs
                Deodorant (triclocarban,    Grove Ave., Cincinnati, OH
                1%) Soap                    45214-1773
------------------------------------------------------------------------
NDA 16-888     Selsun Blue (selenium       Abbott Laboratories, 625
                sulfide) Cream/Shampoo,     Cleveland Ave., Columbus, OH
                1%                          43215-1724
------------------------------------------------------------------------
NDA 17-569     Renoquid (sulfacytine)      Glenwood LLC, 111 Cedar Lane,
                Tablets                     Englewood, NJ 07631
------------------------------------------------------------------------
NDA 17-573     Vanceril (beclomethasone    Schering Corp., 2000
                dipropionate) Inhalation    Galloping Hill Rd.,
                Aerosol                     Kenilworth, NJ 07033
------------------------------------------------------------------------
NDA 17-659     Alupent (metaproterenol     Boehringer Ingelheim
                sulfate) Inhalation         Pharmaceuticals, Inc., 900
                Solution, 5%                Ridgebury Rd., P.O. Box 368,
                                            Ridgefield, CT 06877-0368
------------------------------------------------------------------------
NDA 17-781     Diprosone (betamethasone    Schering Corp.
                dipropionate) Lotion
------------------------------------------------------------------------
NDA 17-820     Dobutrex (dobutamine HCl)   Eli Lilly & Co.
                Sterile Injection
------------------------------------------------------------------------
ANDA 18-023    Lactated Ringer's           B. Braun Medical, Inc., 2525
                Injection USP               McGaw Ave., P.O. Box 19791,
                                            Irvine, CA 92623-9791
------------------------------------------------------------------------
ANDA 18-026    5% Dextrose and 0.9%        Do.
                Sodium Chloride (NaCl)
                Injection
------------------------------------------------------------------------
ANDA 18-046    10% Dextrose Injection USP  Do.
------------------------------------------------------------------------
ANDA 18-047    10% Dextrose and 0.9% NaCl  Do.
                Injection USP
------------------------------------------------------------------------
ANDA 18-184    0.45% NaCl Injection USP    Do.
------------------------------------------------------------------------
ANDA 18-186    1/6 Molar Sodium Lactate    Do.
                Injection USP in Plastic
                Container
------------------------------------------------------------------------
ANDA 18-197    Ibuprofen Tablets           BASF Corp., 8800 Line Ave.,
                                            Shreveport, LA 71106
------------------------------------------------------------------------
ANDA 18-252    Isolyte S (multi-           B. Braun Medical, Inc.
                electrolyte injection)
                Injection
------------------------------------------------------------------------
ANDA 18-256    5% Dextrose in Ringer's     Do.
                Injection
------------------------------------------------------------------------
NDA 18-257     Tonocard (tocainide HCl)    AstraZeneca Pharmaceuticals
                Tablets, 400 mg and 600
                mg
------------------------------------------------------------------------

[[Page 34942]]

 
ANDA 18-274    Isolyte S (multi-           B. Braun Medical, Inc.
                electrolyte injection)
                with 5% Dextrose in
                Plastic Container
------------------------------------------------------------------------
NDA 18-389     Aldomet (methyldopa) Oral   Merck & Co., Inc.
                Suspension, 250 mg/5 mL
------------------------------------------------------------------------
NDA 18-682     TZ-3 (1% tioconazole)       Pfizer, Inc., 235 East 42nd
                Dermal Cream                St., New York, NY 10017
------------------------------------------------------------------------
NDA 18-686     Normodyne (labetalol HCl    Schering Corp.
                USP) Injection, 5 mg/mL
------------------------------------------------------------------------
NDA 18-687     Normodyne (labetalol HCl    Do.
                USP) Tablets
------------------------------------------------------------------------
ANDA 18-721    Ringer's Injection USP      B. Braun Medical, Inc.
------------------------------------------------------------------------
NDA 18-754     Orudis (ketoprofen)         Wyeth Pharmaceuticals
                Capsules, 25 mg, 50 mg,
                and 75 mg
------------------------------------------------------------------------
NDA 18-792     Neopham (amino acids)       Hospira, Inc., 275 North
                Injection                   Field Dr., Dept. 389, Bldg.
                                            2, Lake Forest, IL 60045
------------------------------------------------------------------------
NDA 18-901     Aminess (essential amino    Do.
                acids injection with
                histidine)
------------------------------------------------------------------------
NDA 18-911     Heparin Sodium in 5%        Do.
                Dextrose Injection and
                Heparin Sodium in NaCl
                Injection
------------------------------------------------------------------------
NDA 19-083     Theophylline and 5%         B. Braun Medical, Inc.
                Dextrose Injection
------------------------------------------------------------------------
NDA 19-107     Protropin (somatrem) for    Genentech, Inc., 1 DNA Way
                Injection                   MS242, South San
                                            Francisco, CA 94080-4990
------------------------------------------------------------------------
ANDA 19-138    Alphatrex (betamethasone    Savage Laboratories, 60
                dipropionate cream USP)     Baylis Rd., Melville, NY
                0.05%                       11747
------------------------------------------------------------------------
ANDA 19-143    Alphatrex (betamethasone    Do.
                dipropionate ointment
                USP) 0.05%
------------------------------------------------------------------------
NDA 19-383     Proventil (albuterol        Schering Corp.
                sulfate extended-release
                tablets USP) Repetabs
------------------------------------------------------------------------
NDA 19-401     Pseudo-12 Suspension        Celltech Pharmaceuticals,
                (pseudoephedrine            Inc.
                polistirex extended-
                release suspension)
------------------------------------------------------------------------
NDA 19-523     Cysteine HCl Injection      Hospira, Inc.
                USP, 7.25%
------------------------------------------------------------------------
NDA 19-589     Vancenase AQ                Schering Corp.
                (beclomethasone
                dipropionate) Nasal Spray
------------------------------------------------------------------------
NDA 19-621     Ventolin (albuterol         GlaxoSmithKline
                sulfate) Syrup              Pharmaceuticals, 5 More Dr.,
                                            P.O. Box 13358, Research
                                            Triangle Park, NC 27709
------------------------------------------------------------------------
NDA 20-035     Ergamisol (levamisole HCl)  Johnson & Johnson
                Tablets                     Pharmaceutical Research and
                                            Development, LLC, c/o
                                            Janssen Pharmaceutical
                                            Products, LP, 1125 Trenton-
                                            Harbourton Rd., K1-02B,
                                            Titusville, NJ 08560-0200
------------------------------------------------------------------------
NDA 20-176     VitaPed (multivitamins)     Hospira, Inc.
------------------------------------------------------------------------
NDA 20-338     Differin (adapalene)        Galderma Laboratories, LP,
                Solution, 0.1%              14501 North Freeway, Fort
                                            Worth, TX 76177
------------------------------------------------------------------------
NDA 20-759     Trovan (trovafloxacin       Pfizer, Inc.
                mesylate) Tablets, 100 mg
                and 200 mg
------------------------------------------------------------------------
NDA 20-760     Trovan (alatrofloxacin      Do.
                mesylate) Injection
------------------------------------------------------------------------
NDA 20-847     Esclim (estradiol extended- Women First Healthcare, Inc.,
                release film) Transdermal   380 Lexington Ave., New
                System                      York, NY 10168
------------------------------------------------------------------------
NDA 20-962     Emla (2.5% lidocaine and    AstraZeneca Pharmaceuticals
                2.5% prilocaine)
                Anesthetic Disc
------------------------------------------------------------------------
ANDA 40-023    Adrucil (fluorouracil       Sicor Pharmaceuticals, Inc.,
                injection USP), 50 mg/mL    19 Hughes, Irvine, CA 92618
------------------------------------------------------------------------
ANDA 40-147    Leucovorin Calcium          Hospira, Inc.
                Injection USP, 10 mg
                (base)/mL
------------------------------------------------------------------------
NDA 50-039     Garamycin (gentamicin       Schering Corp.
                sulfate) Ophthalmic
                Solution
------------------------------------------------------------------------

[[Page 34943]]

 
NDA 50-091     Chloroptic                  Allergan, Inc., 2525 Dupont
                (chloramphenicol            Dr., P.O. Box 19534, Irvine,
                ophthalmic solution USP),   CA 92623-9534
                0.5%
------------------------------------------------------------------------
NDA 50-322     Neodecadron (neomycin       Merck & Co., Inc.
                sulfate and dexamethasone
                sodium phosphate) Sterile
                Ophthalmic Solution
------------------------------------------------------------------------
NDA 50-368     Ilotycin (erythromycin)     Eli Lilly & Co.
                Ophthalmic Ointment
------------------------------------------------------------------------
NDA 50-571     CefMax (cefmenoxime HCl)    TAP Pharmaceutical Products,
                Injection                   Inc., 675 North Field Dr.,
                                            Lake Forest, IL 60045
------------------------------------------------------------------------
NDA 50-648     Clindamycin Phosphate       Baxter Healthcare Corp.,
                Injection in 5% Dextrose    Route 120 & Wilson Rd.,
                                            Round Lake, IL 60073
------------------------------------------------------------------------
ANDA 60-429    Sumycin Capsules            Apothecon, c/o Bristol-Myers
                (tetracycline HCl           Squibb Co., P.O. Box 4500,
                capsules USP)               Princeton, NJ 08543-4500
------------------------------------------------------------------------
ANDA 62-480    Gentacidin Solution         Novartis Pharmaceuticals
                (gentamicin sulfate         Corp., 1 Health Plaza, Bldg.
                ophthalmic solution USP)    118, East Hanover, NJ 07936-
                                            1080
------------------------------------------------------------------------
ANDA 62-597    Mytrex (nystatin and        Savage Laboratories
                triamcinolone acetonide
                cream USP) 100,000 units/
                gram (g) and 1 mg/g
------------------------------------------------------------------------
ANDA 62-601    Mytrex (nystatin and        Do.
                triamcinolone acetonide
                ointment USP) 100,000
                units/g and 1 mg/g
------------------------------------------------------------------------
ANDA 62-750    Pipracil (piperacillin for  Wyeth Pharmaceuticals, Inc.
                injection), 2 g, 3 g, and
                4 g
------------------------------------------------------------------------
ANDA 63-186    Cephalexin Capsules USP,    Apothecon, c/o Bristol-Myers
                250 mg and 500 mg           Squibb Co.
------------------------------------------------------------------------
ANDA 64-084    Sterile Bleomycin Sulfate   Sicor Pharmaceuticals, Inc.
                for Injection USP, 15 and
                30 units/vial
------------------------------------------------------------------------
ANDA 70-083    Ibuprofen Tablets USP, 400  BASF Corp.
                mg
------------------------------------------------------------------------
ANDA 70-099    Ibuprofen Tablets USP, 600  Do.
                mg
------------------------------------------------------------------------
ANDA 70-273    Alphatrex (betamethasone    Savage Laboratories
                dipropionate lotion USP),
                0.05%
------------------------------------------------------------------------
ANDA 70-745    Ibuprofen Tablets USP, 800  BASF Corp.
                mg
------------------------------------------------------------------------
ANDA 72-621    Acetylcysteine Solution     Roxane Laboratories, Inc.,
                USP, 10%                    P.O. Box 16532, Columbus, OH
                                            43216
------------------------------------------------------------------------
ANDA 72-622    Acetylcysteine Solution     Do.
                USP, 20%
------------------------------------------------------------------------
ANDA 72-995    Metoclopramide HCl Oral     Do.
                Solution, 10 mg/mL
------------------------------------------------------------------------
ANDA 73-562    Diflunisal Tablets USP,     Do.
                250 mg
------------------------------------------------------------------------
ANDA 73-563    Diflunisal Tablets USP,     Do.
                500 mg
------------------------------------------------------------------------
ANDA 74-166    Toposar (etoposide          Sicor Pharmaceuticals, Inc.
                injection USP), 20 mg/mL
------------------------------------------------------------------------
ANDA 74-541    Cimetidine HCl Oral         Roxane Laboratories, Inc.
                Solution, 30 mg/5 mL
------------------------------------------------------------------------
ANDA 74-663    Acyclovir Sodium for        Hospira, Inc.
                Injection USP, 500 mg
                base/vial and 1 g base/
                vial
------------------------------------------------------------------------
ANDA 75-179    Nabumetone Tablets          Copley Pharmaceutical, Inc.,
                                            1090 Horsham Rd., P.O. Box
                                            1090, North Wales, PA 19454
------------------------------------------------------------------------
ANDA 75-875    Carbamazepine Oral          Taro Pharmaceutical
                Suspension USP, 100 mg/5    Industries, Ltd., c/o Taro
                mL                          Pharmaceuticals, U.S. Agent,
                                            5 Skyline Dr., Hawthorne, NY
                                            10532
------------------------------------------------------------------------
ANDA 80-643    Diphenhydramine HCl Elixir  Roxane Laboratories, Inc.
                USP, 25 mg/10 mL
------------------------------------------------------------------------
ANDA 81-225    Adrucil (etopside           Sicor Pharmaceuticals, Inc.
                injection USP), 50 mg/mL
------------------------------------------------------------------------
ANDA 83-261    Pentobarbital Sodium        Wyeth Pharmaceuticals
                Injection USP
------------------------------------------------------------------------
ANDA 83-383    Diucardin                   Do.
                (hydroflumethiazide
                tablets USP) Tablets, 50
                mg
------------------------------------------------------------------------

[[Page 34944]]

 
ANDA 84-015    Bleph-10 (sulfacetamide     Allergan, Inc.
                sodium ophthalmic
                ointment USP) Ophthalmic
                Ointment, 10%
------------------------------------------------------------------------
ANDA 84-514    Dilor (dyphylline tablets   Savage Laboratories
                USP), 200 mg
------------------------------------------------------------------------
ANDA 84-751    Dilor-400 (dyphylline       Do.
                tablets USP), 400 mg
------------------------------------------------------------------------
ANDA 85-035    Diphenoxylate HCl and       R & S Pharma, LLC, 8407
                Atropine Sulfate Tablets    Austin Tracy Rd., Fountain
                USP, 2.5 mg and 0.025 mg    Run, KY 42133
------------------------------------------------------------------------
ANDA 85-961    Methocarbamol Tablets USP,  Clonmel Healthcare Ltd., c/o
                500 mg                      STADA Pharmaceuticals, Inc.,
                                            U.S. Agent, 5 Cedar Brook
                                            Dr., Cranbury, NJ 08512
------------------------------------------------------------------------
ANDA 85-963    Methocarbomal Tablets USP,  Do.
                750 mg
------------------------------------------------------------------------
ANDA 86-899    Isoetharine HCl Inhalation  Roxane Laboratories, Inc.
                Solution USP, 1%
------------------------------------------------------------------------
ANDA 87-450    Chlorthalidone Tablets      Clonmel Healthcare Ltd.
                USP, 50 mg
------------------------------------------------------------------------
ANDA 87-451    Chlorthalidone Tablets      Do.
                USP, 25 mg
------------------------------------------------------------------------
ANDA 87-500    Aminophylline Tablets USP,  Roxane Laboratories, Inc.
                100 mg
------------------------------------------------------------------------
ANDA 87-501    Aminophylline Tablets USP,  Do.
                200 mg
------------------------------------------------------------------------
ANDA 88-253    T-Phyl (theophylline)       The Purdue Frederick Co.
                Extended-Release Tablets,
                200 mg
------------------------------------------------------------------------

    Therefore, under section 505(e), of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(e)), and under authority delegated to the 
Director, Center for Drug Evaluation and Research, by the Commissioner 
of Food and Drugs, approval of the applications listed in the table in 
this document, and all amendments and supplements thereto, is hereby 
withdrawn, effective June 16, 2006.

    Dated: May 23, 2006.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E6-9440 Filed 6-15-06; 8:45 am]
BILLING CODE 4160-01-S
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