Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 Abbreviated New Drug Applications, 10651-10657 [05-4158]

Download as PDF Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices growth between the smoking process and distribution at retail, and (3) recontamination with L. monocytogenes during the manufacturing and/or processing of smoked finfish. Listeria monocytogenes contamination is a problem in coldsmoked finfish because the heat applied during processing is not sufficient to inactivate the organism, and the fish are consumed without further cooking. Cold-smoked finfish may become contaminated during processing due to inadequate sanitation, particularly because of insufficient cleaning and sterilizing of the slicer. For hot-smoked finfish, although L. monocytogenes is killed by adequate hot-smoking, recontamination after hot-smoking can result in high numbers of the organism in the finished products. Additionally, the ability of the organism to grow under both refrigerated aerobic and anaerobic conditions makes it a concern in products packed in permeable wrappers and under modified atmosphere or vacuum. This sealing of the product extends shelf-life and, therefore, provides additional time for the organism to grow. Preventive Controls for L. monocytogenes in Retail and Foodservice Establishments: FDA is evaluating the Food Code to determine whether it should consider recommending revisions to the provisions addressing preventive controls for L. monocytogenes in retail and foodservice establishments. Specifically, FDA will take the following steps: (1) Review the Food Code to determine whether it should consider recommending revisions to the provisions that address preventive controls, such as approved source, date marking, and cold holding times and temperatures; and (2) in conjunction with the Conference for Food Protection, issue guidance to the retail and food service industries and State and local regulatory professionals on the use of Hazard Analysis Critical Control Point (HACCP) principles to identify and control risk factors contributing to foodborne illness. FDA intends for such guidance to discuss intervention strategies that industry can use to control L. monocytogenes and other pathogens. II. Request for Comments and for Scientific Data and Information Smoked Finfish Risk Assessment: FDA requests comments on the risk assessment approach outlined previously in this document and the submission of data and any information relevant to this risk assessment. The agency specifically requests information VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 for the following: (1) L. monocytogenes levels in raw fish, smoked fish, and finished product; (2) effect of mitigation measures (e.g., ozonation, acidified sodium chlorite) to reduce L. monocytogenes levels in raw and finished product; (3) potential for transfer of L. monocytogenes to food from contaminated food contact and noncontact surfaces during manufacturing and/or processing (e.g., equipment, workers, floor drains, etc.); (4) potential for transfer of L. monocytogenes from the slicer to coldsmoked fish; (5) impact of adding inhibitors (e.g., bacteriocins and bacteriocins-producing bacterial strains or sodium lactate) to smoked finfish to reduce or prevent L. monocytogenes growth; (6) impact of frozen versus refrigerated storage conditions on levels of L. monocytogenes; (7) impact of time and temperature on levels of L. monocytogenes for commercial and home storage conditions of finished product; and (8) effect of training regarding sanitation and hygienic practices on reducing the levels of L. monocytogenes in smoked finfish. Preventive Controls for L. monocytogenes in Retail and Foodservice Establishments: Under the FDA/CDC Listeria Action Plan, FDA is continuing its commitment to review the Food Code to determine whether it should consider recommending revisions to the provisions that address preventive controls for Listeria in retail and foodservice establishments. The agency specifically requests the following data and information: (1) L. monocytogenes levels in products stored in retail and foodservice establishments; (2) levels of environmental contamination and harborage of L. monocytogenes on food contact and nonfood contact surfaces in retail and foodservice establishments (e.g., equipment, workers, floor drains, etc.); (3) effects of short- and long-term refrigerated storage on levels of L. monocytogenes in retail and foodservice establishments; (4) impact of time and temperature on levels of L. monocytogenes in products stored in retail and foodservice establishments; (5) efficacy of cleaning procedures and sanitizing agents on environmental surfaces and utensils; (6) frequency of use and impact of adding inhibitors to food products in retail and foodservice establishments to reduce or prevent L. monocytogenes growth; and (7) effect of training regarding hygienic practices and sanitation on levels of L. monocytogenes in products in retail and foodservice establishments. Interested persons should submit comments, scientific data, and PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 10651 information to the Division of Dockets Management (see ADDRESSES). Three copies of all comments, scientific data, and information are to be submitted. Individuals submitting written information or anyone submitting electronic comments may submit one copy. Submissions are to be identified with the docket number found in brackets in the heading of this document and may be accompanied by supporting information. Received submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Information submitted after the closing date will not be considered except by petition under 21 CFR 10.30. III. References The following references are on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. U.S. Department of Health and Human Services, Healthy People 2010, v. 1. Washington, DC, 2000, http:// www.healthypeople.gov. 2. U.S. Department of Health and Human Services and U.S. Department of Agriculture/ Food Safety and Inspection Service, ‘‘Quantitative Assessment of Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods,’’ September 2003, http://www.foodsafety.gov/~dms/lmr2– toc.html. 3. U.S. Department of Health and Human Services, Food and Drug Administration/ Centers for Disease Control and Prevention, ‘‘Reducing the Risk of Listeria monocytogenes FDA/CDC 2003 Update of the Listeria Action Plan,’’ November 2003, http:/ /www.cfsan.fda.gov/~dms/lmr2plan.html. 4. U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Food Code, 2001, http:/ /www.cfsan.fda.gov/~dms/fc01–toc.html. Dated: February 25, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–4217 Filed 3–3–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0058] Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. E:\FR\FM\04MRN1.SGM 04MRN1 10652 ACTION: Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 76 new drug applications (NDAs) and 60 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. EFFECTIVE DATE: April 4, 2005. 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. Application No. 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 NDA 6–095 Tubocurarine Chloride Injection Hospira, Inc., 275 North Field Dr., Bldg. 2–J45–2, Lake Forest, IL 60045–5046 NDA 6–412 Decapryn (doxylamine succinate) Tablets and Syrup Aventis Pharmaceuticals, Inc., 200 Crossing Blvd., Bridgewater, NJ 08807–0890 NDA 6–460 Protamine Sulfate Injection USP Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 NDA 8–032 Telepaque (iopanoic acid) Tablets Amersham Health, 101 Carnegie Center, Princeton, NJ 08540 NDA 10–288 Betadine (10% povidone iodine) Solution and Isodine (10% povidone iodine) Solution The Purdue Frederick Co., One Stamford Forum, Stamford, CT 06901–3431 NDA 11–097 Dimetane (brompheniramine maleate) Elixir Wyeth Consumer Healthcare, Five Giralda Farms, Madison, NJ 07940 NDA 11–270 Furoxone (furazolidone) Tablets Shire Laboratories, Inc., c/o Shire Pharmaceutical Development, Inc., 1801 Research Blvd., suite 600, Rockville, MD 20850 NDA 11–323 Furoxone (furazolidone) Oral Suspension Do. NDA 11–325 Vesprin (triflupromazine hydrochloride (HCl)) Injection, 10 milligrams (mg)/milliliter (mL) and 20 mg/mL Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543–4500 NDA 11–367 Enzactin (triacetin) Spray Wyeth Consumer Healthcare NDA 12–265 Naqua (trichlormethiazide) Tablets and Naquival (trichlormethiazide and reserpine) Tablets Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033 NDA 12–320 Rauzide (rauwolfia serpentine with bendroflumethiazide) Tablets and Rautrax-N Tablets Apothecon, c/o Bristol-Myers Squibb Co. NDA 12–728 Ortho-Novum 1/50–21 (norethindrone and mestranol) Tablets Ortho-McNeil Pharmaceuticals, Inc., c/o Johnson & Johnson Research and Development, L.L.C., 920 Route 202 South, Box 300, Raritan, NJ 08869–0602 NDA 16–993 Adsorbotear Ophthalmic Solution Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, TX 76134 NDA 17–471 Sodium Pertechnetate Tc–99m (technetium Tc– 99m sodium pertechnetate) Solution Amersham Health NDA 17–488 Modicon 21 (norethindrone and ethinyl estradiol) Tablets Ortho-McNeil Pharmaceuticals, Inc., c/o Johnson & Johnson Research and Development, L.L.C. NDA 17–489 Ortho-Novum 1/35–21 (norethindrone and ethinyl estradiol) Tablets and Neocon Tablets (norethindrone and ethinyl estradiol) Do. NDA 17–561 Celstone (betamethasone sodium phosphate USP) Injection Schering Corp. NDA 17–601 Optimine (azatadine maleate USP) Tablets Do. VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1 10653 Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices Application No. Drug Applicant NDA 17–603 Novafed ER (pseudoephedrine HCl) Tablets, 120 mg Aventis Pharmaceuticals, Inc. NDA 17–657 Cephulac (lactulose fumarate) Syrup Do. NDA 17–661 Tavist (clemastine fumarate) Tablets and Tavist– 1 (clemastine fumarate) Tablets Novartis Consumer Health, Inc., 200 Kimball Dr., Parsippany, NJ 07054–0622 NDA 17–687 Xenon Xe–133 Gas Amersham Health NDA 17–700 Gallium Citrate Ga–67 Injection Do. NDA 17–773 Technetium Tc–99m MAA Kit Amersham Health NDA 17–884 Chronulac (lactulose) Syrup Aventis Pharmaceuticals, Inc. NDA 18–030 Dextrose and Sodium Chloride (NaCl) Injection USP B. Braun Medical, Inc., 2525 McGaw Ave., P.O. Box 19791, Irvine, CA 92623–9791 NDA 18–062 Proventil (albuterol sulfate) Syrup Schering Corp. NDA 18–229 Dextrose and NaCl Injection USP B. Braun Medical, Inc. NDA 18–269 Isolyte E (multi-electrolyte injection) with 5% Dextrose Do. NDA 18–270 Isolyte M (multi-electrolyte injection) with 5% Dextrose Do. NDA 18–271 Isolyte R (multi-electrolyte injection) with 5% Dextrose Do. NDA 18–273 Isolyte H (multi-electrolyte injection) with 5% Dextrose Do. NDA 18–335 Amerscan (technetium Tc–99m medronate) MDP Kit Amersham Health NDA 18–358 Dextrose Injection USP, 2.5% B. Braun Medical, Inc. NDA 18–386 Dextrose and NaCl Injection USP Do. NDA 18–506 Trinalin Repetabs (azatadine maleate and pseudoephedrine sulfate tablets) Schering Corp. ANDA 18–621 Nitro-Bid IV (nitroglycerin) Injection, 5 mg/mL Aventis Pharmaceuticals, Inc. NDA 18–654 Versed (midazolam HCl) Injection Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110–1199 NDA 18–675 Tavist (clemastine fumarate) Syrup Novartis Consumer Health, Inc. ANDA 18–889 Metronizadole in NaCl Injection Abbott Laboratories, 200 Abbott Park Rd., D–389 J45–2, Abbott Park, IL 60064–6133 NDA 18–899 Isolyte E (multi-electrolyte injection) B. Braun Medical, Inc. NDA 18–924 Aminophylline in 0.45% NaCl Injection Hospira, Inc. NDA 18–967 Lidocaine HCl and 5% Dextrose Injection B. Braun Medical, Inc. NDA 19–004 Ortho-Novum (nonrethindrone and ethinyl estradiol) 7/14-21 and -28 Tablets Ortho-McNeil Pharmaceuticals, Inc., c/o Johnson & Johnson Research and Development, L.L.C. NDA 19–006 Isolyte S, pH 7.4 (multi-electrolyte injection) B. Braun Medical, Inc. NDA 19–025 Isolyte P (multi-electrolyte injection) with 5% Dextrose Do. NDA 19–033 Bretylium Tosylate Injection Hospira, Inc. NDA 19–042 Heparin Sodium in NaCl Injection B. Braun Medical, Inc. NDA 19–077 Sterile Water for Injection USP Do. VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1 10654 Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices Application No. Drug Applicant NDA 19–134 Heparin Sodium in 5% Dextrose Injection Do. NDA 19–135 Heparin Sodium in 0.9% NaCl Injection Do. NDA 19–243 Proventil (albuterol sulfate) Inhalation Solution Schering Corp. NDA 19–471 Cardizem SR Capsules (diltiazem HCl), 60 mg, 90 mg, 120 mg, and 180 mg Biovail Laboratories, Inc., c/o Biovail Technologies Ltd., 700 Route 202/206 North, Bridgewater, NJ 08807–0980 NDA 19–478 Adalat (nifedipine) Capsules Bayer Pharmaceuticals Corp., 400 Morgan Lane, West Haven, CT 06516–4175 NDA 19–604 Volmax (albuterol sulfate) Extended- Release Tablets Muro Pharmaceuticals, Inc., 890 East St., Tewksbury, MA 01876–1496 NDA 19–616 Penetrex (enoxacin) Tablets Aventis Pharmaceuticals, Inc. NDA 19–698 Toradol (ketorolac tromethamine) Injection Roche Palo Alto, LLC, c/o Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110 NDA 19–817 Persantine (dipyridamole) Injection Boehringer Ingleheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877–0368 NDA 19–978 Bupivacaine HCl Injection USP Hospira, Inc. NDA 20–542 Dopamine HCl in 5% Dextrose Injection Do. NDA 20–677 Zagam (sparfloxacin) Tablets, 200 mg Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504– 4310 NDA 20–755 Caverject (alprostadil) Injection Pfizer, Inc., 7000 Portage Rd., Kalamazoo, MI 49001 NDA 20–942 Versed (midazolam HCl) Syrup, 2 mg/mL Hoffman-La Roche, Inc. NDA 20–997 Chirocaine (levobupivacaine HCl) Injection Purdue Pharma L.P., One Stamford Forum, Stamford, CT 06901–3431 NDA 50–010 Ilosone (erythromycin estolate oral suspension) Liquid Eli Lilly & Co. NDA 50–011 Pathocil (dicloxacillin sodium) Capsules Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101–8299 NDA 50–199 Unipen (nafcillin sodium) Powder for Oral Solution Do. NDA 50–271 Achromycin (tetracycline HCl) Powder for Reconstitution Lederle, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101–8299 NDA 50–320 Unipen (nafcillin sodium) Injection Wyeth Pharmaceuticals NDA 50–365 Ilosone (erythromycin estolate USP) Pulvules Eli Lilly & Co. NDA 50–369 Ilotycin (erythromycin) Tablets Do. NDA 50–426 Ilosone (erythromycin estolate USP) Tablets Do. NDA 50–427 Minocin (minocycline HCl) Diagnostic Susceptibility Powder Lederle, c/o Wyeth Pharmaceuticals NDA 50–437 Garamycin (gentamicin sulfate) Injection, 10 mg/ mL Schering Corp. NDA 50–462 Unipen (nafcillin sodium) Tablets Wyeth Pharmaceuticals NDA 50–505 Garamycin (gentamicin sulfate) Injection, 2 mg/ mL Schering Corp. NDA 50–549 Mezlin (mezlocillin sodium monohydrate) Sterile Powder for Injection Bayer Pharmaceuticals Corp. VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1 10655 Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices Application No. Drug Applicant ANDA 60–134 Ledercillin VK (penicillin V potassium) Tablets, 250 mg and 500 mg Lederle Laboratories, Pearl River, NY 10965 ANDA 60–136 Ledercillin VK (penicillin V potassium) for Oral Suspension, 125 mg/5 mL and 250 mg/5 mL Do. ANDA 60–413 Penicillin G Potassium Tablets Wyeth Laboratories ANDA 60–431 Ilosone (erythromycin estolate USP) Chewable Tablets Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285 ANDA 60–559 Ilosone (erythromycin estolate) Oral Suspension Liquid Do. ANDA 60–625 Omnipen (ampicillin for oral suspension USP) for Oral Suspension Wyeth Laboratories ANDA 60–626 Omnipen-N (ampicillin sodium) Injection, 125 mg, 250 mg, 500 mg, 1 gram (g), and 2 g/vial Do. ANDA 61–655 Kantrex (kanamycin sulfate) Injection Apothecon, c/o Bristol-Myers Squibb Co. ANDA 61–675 Wyamycin S (erythromycin stearate tablets USP), 250 mg and 500 mg Wyeth Laboratories ANDA 61–685 Tetracycline HCl Capsules USP, 250 mg and 500 mg Do. ANDA 61–769 Cephapirin for Injection USP Apothecon, c/o Bristol-Myers Squibb Co. ANDA 61–893 Ilosone (erythromycin estolate USP) for Oral Suspension Dista, c/o Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285 ANDA 61–894 Ilosone (erythromycin estolate) Oral Suspension Do. ANDA 61–895 Ilosone (erythromycin estolate USP) Chewable Tablets Do. ANDA 61–896 Ilosone (erythromycin estolate USP) Tablets Do. ANDA 61–897 Ilosone (erythromycin estolate USP) Pulvules Do. ANDA 61–910 Ilotycin (erythromycin) Enteric Coated Tablets Do. ANDA 62–123 Wyamycin E (erythromycin ethylsuccinate) Oral Suspension, 200 mg/5 mL and 400 mg/5 mL Wyeth Laboratories ANDA 62–131 Wymox (amoxicillin) for Oral Suspension Do. ANDA 62–501 Gentacidin Ophthalmic Ointment (gentamicin sulfate ophthalmic ointment USP) 0.3% Novartis Ophthalmics, Inc., 11695 John Creek Pkwy., Duluth, GA 30097–1523 ANDA 62–544 Dexacidin (neomycin sulfate, polymyxin B sulfate, and dexamethasone) Ophthalmic Suspension Novartis Pharmaceuticals Corp., One Health Plaza, Building 105 Eisenhower, East Hanover, NJ 07936 ANDA 62–566 Dexacidin (neomycin sulfate, polymyxin B sulfate, and dexamethasone) Ophthalmic Ointment Novartis Ophthalmics, Inc. ANDA 62–717 Unipen (nafcillin sodium) Injection, 500–mg, 1–g, and 2–g vials Wyeth Laboratories ANDA 62–718 Omnipen-N (ampicillin sodium) Injection, 125– mg, 250–mg, 500–mg, 1–g, and 2–g vials Do. ANDA 62–726 Kenamycin Sulfate Capsules USP, 500 mg Apothecon, c/o Bristol-Myers Squibb Co. ANDA 62–986 Cephalexin For Oral Suspension USP, 125 mg/5 mL Do. ANDA 63–107 Emgel (erythromycin) Topical Gel, 2% GlalxoSmithKline Consumer Healthcare, L.P., 1500 Littleton Rd., Parsippany, NJ 07054– 3884 VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1 10656 Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices Application No. Drug Applicant ANDA 71–159 Nitro-Bid (nitroglycerin) Injection, 10 mg/mL Aventis Pharmaceuticals, Inc. ANDA 74–194 Loperamide HCl Tablets, 2 mg L. Perrigo Co., 515 Eastern Ave., Allegan, MI 49010 ANDA 74–539 Tamoxifen Citrate Tablets USP, 10 mg Pharmachemie B.V., c/o Teva Pharmaceuticals, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454–1090 ANDA 75–114 Acyclovir Injection, 50 mg/mL Abbott Laboratories ANDA 75–583 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg Apothecon Inc., c/o Bristol-Myers Squibb Co. ANDA 75–729 Famotidine Injection, 0.4 mg/mL Abbott Laboratories ANDA 76–214 Sotalol HCl Tablets, 80 mg, 120 mg, and 160 mg TorPharm, c/o Apotex Corp., 616 Heathrow Dr., Lincolnshire, IL 60069 ANDA 83–823 Nicolar (niacin) Tablets, 500 mg Aventis Pharmaceuticals, Inc. ANDA 83–892 Selenium Sulfide Lotion USP Allergan, 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623 ANDA 84–476 Domeboro (acetic acid, glacial and aluminum acetate) SolutionBayer Pharmaceuticals Corp. ANDA 85–113 Chlordiazepoxide HCl Capsules USP, 10 mg Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544 ANDA 85–187 Slo-Phyllin (theophylline) Syrup, 80 mg/15 mL Aventis Pharmaceuticals, Inc. ANDA 85–202 Slo-Phyllin (theophylline) Tablets, 100 mg Do. ANDA 85–204 Slo-Phyllin (theophylline) Tablets, 200 mg Do. ANDA 86–126 Nitrong SR (nitroglycerin) Tablets, 6.5 mg Do. ANDA 86–137 Nitrong (nitroglycerin) Ointment, 2% Do. ANDA 86–138 Nitrong (nitroglycerin) Tablets, 2.6 mg Do. ANDA 86–681 Acetaminophen and Codeine Phospate Tablets USP, 300 mg/30 mg Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ 07207 ANDA 87–715 Nitrong SR (nitroglycerin) Tablets, 9 mg Do. ANDA 87–892 Slo-Bid (theophylline) Capsules, 100 mg Aventis Pharmaceuticals, Inc. ANDA 87–893 Slo-Bid (theophylline) Capsules, 200 mg Do. ANDA 87–894 Slo-Bid (theophylline) Capsules, 300 mg Do. ANDA 88–082 Hydrocortisone USP, Micronized Powder (Nonsterile) Paddock Laboratories, Inc., 3940 Quebec Ave. South, Minneapolis, MN 55427 ANDA 88–269 Slo-Bid (theophylline) Capsules, 50 mg Aventis Pharmaceuticals, Inc. ANDA 88–782 NTS 5 (nitroglycerin) Transdermal Systems Hercon Laboratories Corp., 101 Sinking Springs Lake, P.O. Box 467, Emigsville, PA 17318 ANDA 88–783 NTS 15 (nitroglycerin) Transdermal Systems Do. ANDA 88–791 Vasocidin (sulfacetamide sodium and prednisolone acetate) Ophthalmic Ointment Novartis Ophthalmics, Inc. ANDA 89–047 Sulf–15 (sulfacetamide sodium ophthalmic solution USP), 15% Do. ANDA 89–516 NTS 10 (nitroglycerin) Transdermal Systems Hercon Laboratories Corp. ANDA 89–539 Slo-Bid (theophylline) Capsules, 75 mg Aventis Pharmaceuticals, Inc. ANDA 89–540 Slo-Bid (theophylline) Capsules, 125 mg Do. VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1 Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices 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, approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective April 4, 2005. Dated: January 31, 2005. Steven Galson, Acting Director, Center for Drug Evaluation and Research. [FR Doc. 05–4158 Filed 3–3–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Submit written requests for single copies of the revised guidance to the Division of Compliance Policy (HFC–230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance may be sent. Submit written comments on the guidance to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. ADDRESSES: [Docket No. 2003D–0554] Revised Compliance Policy Guide Regarding Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability FOR FURTHER INFORMATION CONTACT: Domenic Veneziano, Office of Regulatory Affairs (HFC–100), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 703–621– 7809. SUPPLEMENTARY INFORMATION: Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of draft revisions to Compliance Policy Guide (CPG) Sec. 110.310 entitled ‘‘Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.’’ The CPG provides written guidance to FDA and Customs and Border Protection (CBP) staff on enforcement of section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency’s implementing regulations, which require prior notice for food imported or offered for import into the United States. The CPG has been revised to provide additional guidance to FDA and CBP staff regarding specific situations covering routine shipments of food that are transported through the United States, arriving from and exiting to the same country, and regarding the Harmonized Tariff Schedule (HTS) code that is part of the planned shipment information. DATES: The draft revisions to the CPG are found in section C, items 7 and 8. Submit written or electronic comments concerning the draft revisions to the CPG by April 4, 2005. You may submit written or electronic comments on the other sections of the CPG at any time. VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 10657 II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the revised CPG. Submit a single copy of electronic copies or two copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The revised CPG and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access An electronic version of the revised CPG is available on the Internet at http:/ /www.fda.gov/ora under ‘‘Compliance References.’’ Dated: February 24, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–4218 Filed 3–3–05; 8:45 am] BILLING CODE 4160–01–S I. Background FDA is announcing the availability of a draft revision to CPG Sec. 110.310 entitled ‘‘Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.’’ This revised guidance is issued with CBP concurrence and explains to FDA and CBP staff the new FDA and CBP policies on enforcement of section 307 of the Bioterrorism Act and its implementing regulations, which require prior notice to FDA of all food imported or offered for import into the United States (21 CFR part 1.276 through 1.285). FDA is considering taking these steps while the prior notice final rule is under development to provide additional flexibility in filing prior notice when, due to the geography, the only practical transportation route available for the shipment is through the United States and when there is a prior notice violation because the prior notice does not include the 6-digit HTS code for the article of food. FDA is issuing the revisions to the CPG as level 1 draft guidance consistent with FDA’s good guidance practices regulation § 10.115 (21 CFR 10.115). The draft revisions to the CPG represent the agency’s current thinking on its enforcement policy concerning prior notice. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. The draft revisions to the CPG are found in section C, items 7 and 8. PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Organ Transplantation; Request for Nominations for Voting Members Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: SUMMARY: The Health Resources and Services Administration (HRSA) is requesting nominations to fill up to 13 vacancies on the Advisory Committee on Organ Transplantation (ACOT). The ACOT was established by the Amended Final Rule of the Organ Procurement and Transplantation Network (OPTN) (42 CFR Part 121) and, in accordance with Pub. L. 92–463, was chartered on September 1, 2000. DATES: The agency must receive nominations on or before April 4, 2005. ADDRESSES: All nominations should be submitted to the Executive Director, Advisory Committee on Organ Transplantation, Healthcare Systems Bureau, HRSA, Parklawn Building, Room 12C–06, 5600 Fishers Lane, Rockville, Maryland 20857. Federal Express, Airborne, UPS, etc., mail delivery should be addressed to Executive Director, Advisory Committee on Organ Transplantation, Healthcare Systems Bureau, HRSA, at the above address. E:\FR\FM\04MRN1.SGM 04MRN1

Agencies

[Federal Register Volume 70, Number 42 (Friday, March 4, 2005)]
[Notices]
[Pages 10651-10657]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0058]


Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug 
Applications and 60 Abbreviated New Drug Applications

AGENCY:  Food and Drug Administration, HHS.

[[Page 10652]]


ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is withdrawing 
approval of 76 new drug applications (NDAs) and 60 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.

EFFECTIVE DATE:  April 4, 2005.

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 6-095             Tubocurarine Chloride     Hospira, Inc., 275 North
                       Injection                 Field Dr., Bldg. 2-J45-
                                                 2, Lake Forest, IL
                                                 60045-5046
------------------------------------------------------------------------
NDA 6-412             Decapryn (doxylamine      Aventis Pharmaceuticals,
                       succinate) Tablets and    Inc., 200 Crossing
                       Syrup                     Blvd., Bridgewater, NJ
                                                 08807-0890
------------------------------------------------------------------------
NDA 6-460             Protamine Sulfate         Eli Lilly and Co., Lilly
                       Injection USP             Corporate Center,
                                                 Indianapolis, IN 46285
------------------------------------------------------------------------
NDA 8-032             Telepaque (iopanoic       Amersham Health, 101
                       acid) Tablets             Carnegie Center,
                                                 Princeton, NJ 08540
------------------------------------------------------------------------
NDA 10-288            Betadine (10% povidone    The Purdue Frederick
                       iodine) Solution and      Co., One Stamford
                       Isodine (10% povidone     Forum, Stamford, CT
                       iodine) Solution          06901-3431
------------------------------------------------------------------------
NDA 11-097            Dimetane                  Wyeth Consumer
                       (brompheniramine          Healthcare, Five
                       maleate) Elixir           Giralda Farms, Madison,
                                                 NJ 07940
------------------------------------------------------------------------
NDA 11-270            Furoxone (furazolidone)   Shire Laboratories,
                       Tablets                   Inc., c/o Shire
                                                 Pharmaceutical
                                                 Development, Inc., 1801
                                                 Research Blvd., suite
                                                 600, Rockville, MD
                                                 20850
------------------------------------------------------------------------
NDA 11-323            Furoxone (furazolidone)   Do.
                       Oral Suspension
------------------------------------------------------------------------
NDA 11-325            Vesprin (triflupromazine  Apothecon, c/o Bristol-
                       hydrochloride (HCl))      Myers Squibb Co., P.O.
                       Injection, 10             Box 4500, Princeton, NJ
                       milligrams (mg)/          08543-4500
                       milliliter (mL) and 20
                       mg/mL
------------------------------------------------------------------------
NDA 11-367            Enzactin (triacetin)      Wyeth Consumer
                       Spray                     Healthcare
------------------------------------------------------------------------
NDA 12-265            Naqua                     Schering Corp., 2000
                       (trichlormethiazide)      Galloping Hill Rd.,
                       Tablets and Naquival      Kenilworth, NJ 07033
                       (trichlormethiazide and
                       reserpine) Tablets
------------------------------------------------------------------------
NDA 12-320            Rauzide (rauwolfia        Apothecon, c/o Bristol-
                       serpentine with           Myers Squibb Co.
                       bendroflumethiazide)
                       Tablets and Rautrax-N
                       Tablets
------------------------------------------------------------------------
NDA 12-728            Ortho-Novum 1/50-21       Ortho-McNeil
                       (norethindrone and        Pharmaceuticals, Inc.,
                       mestranol) Tablets        c/o Johnson & Johnson
                                                 Research and
                                                 Development, L.L.C.,
                                                 920 Route 202 South,
                                                 Box 300, Raritan, NJ
                                                 08869-0602
------------------------------------------------------------------------
NDA 16-993            Adsorbotear Ophthalmic    Alcon Laboratories,
                       Solution                  Inc., 6201 South
                                                 Freeway, Fort Worth, TX
                                                 76134
------------------------------------------------------------------------
NDA 17-471            Sodium Pertechnetate Tc-  Amersham Health
                       99m (technetium Tc-99m
                       sodium pertechnetate)
                       Solution
------------------------------------------------------------------------
NDA 17-488            Modicon 21                Ortho-McNeil
                       (norethindrone and        Pharmaceuticals, Inc.,
                       ethinyl estradiol)        c/o Johnson & Johnson
                       Tablets                   Research and
                                                 Development, L.L.C.
------------------------------------------------------------------------
NDA 17-489            Ortho-Novum 1/35-21       Do.
                       (norethindrone and
                       ethinyl estradiol)
                       Tablets and Neocon
                       Tablets (norethindrone
                       and ethinyl estradiol)
------------------------------------------------------------------------
NDA 17-561            Celstone (betamethasone   Schering Corp.
                       sodium phosphate USP)
                       Injection
------------------------------------------------------------------------
NDA 17-601            Optimine (azatadine       Do.
                       maleate USP) Tablets
------------------------------------------------------------------------

[[Page 10653]]

 
NDA 17-603            Novafed ER                Aventis Pharmaceuticals,
                       (pseudoephedrine HCl)     Inc.
                       Tablets, 120 mg
------------------------------------------------------------------------
NDA 17-657            Cephulac (lactulose       Do.
                       fumarate) Syrup
------------------------------------------------------------------------
NDA 17-661            Tavist (clemastine        Novartis Consumer
                       fumarate) Tablets and     Health, Inc., 200
                       Tavist-1 (clemastine      Kimball Dr.,
                       fumarate) Tablets         Parsippany, NJ 07054-
                                                 0622
------------------------------------------------------------------------
NDA 17-687            Xenon Xe-133 Gas          Amersham Health
------------------------------------------------------------------------
NDA 17-700            Gallium Citrate Ga-67     Do.
                       Injection
------------------------------------------------------------------------
NDA 17-773            Technetium Tc-99m MAA     Amersham Health
                       Kit
------------------------------------------------------------------------
NDA 17-884            Chronulac (lactulose)     Aventis Pharmaceuticals,
                       Syrup                     Inc.
------------------------------------------------------------------------
NDA 18-030            Dextrose and Sodium       B. Braun Medical, Inc.,
                       Chloride (NaCl)           2525 McGaw Ave., P.O.
                       Injection USP             Box 19791, Irvine, CA
                                                 92623-9791
------------------------------------------------------------------------
NDA 18-062            Proventil (albuterol      Schering Corp.
                       sulfate) Syrup
------------------------------------------------------------------------
NDA 18-229            Dextrose and NaCl         B. Braun Medical, Inc.
                       Injection USP
------------------------------------------------------------------------
NDA 18-269            Isolyte E (multi-         Do.
                       electrolyte injection)
                       with 5% Dextrose
------------------------------------------------------------------------
NDA 18-270            Isolyte M (multi-         Do.
                       electrolyte injection)
                       with 5% Dextrose
------------------------------------------------------------------------
NDA 18-271            Isolyte R (multi-         Do.
                       electrolyte injection)
                       with 5% Dextrose
------------------------------------------------------------------------
NDA 18-273            Isolyte H (multi-         Do.
                       electrolyte injection)
                       with 5% Dextrose
------------------------------------------------------------------------
NDA 18-335            Amerscan (technetium Tc-  Amersham Health
                       99m medronate) MDP Kit
------------------------------------------------------------------------
NDA 18-358            Dextrose Injection USP,   B. Braun Medical, Inc.
                       2.5%
------------------------------------------------------------------------
NDA 18-386            Dextrose and NaCl         Do.
                       Injection USP
------------------------------------------------------------------------
NDA 18-506            Trinalin Repetabs         Schering Corp.
                       (azatadine maleate and
                       pseudoephedrine sulfate
                       tablets)
------------------------------------------------------------------------
ANDA 18-621           Nitro-Bid IV              Aventis Pharmaceuticals,
                       (nitroglycerin)           Inc.
                       Injection, 5 mg/mL
------------------------------------------------------------------------
NDA 18-654            Versed (midazolam HCl)    Hoffman-La Roche, Inc.,
                       Injection                 340 Kingsland St.,
                                                 Nutley, NJ 07110-1199
------------------------------------------------------------------------
NDA 18-675            Tavist (clemastine        Novartis Consumer
                       fumarate) Syrup           Health, Inc.
------------------------------------------------------------------------
ANDA 18-889           Metronizadole in NaCl     Abbott Laboratories, 200
                       Injection                 Abbott Park Rd., D-389
                                                 J45-2, Abbott Park, IL
                                                 60064-6133
------------------------------------------------------------------------
NDA 18-899            Isolyte E (multi-         B. Braun Medical, Inc.
                       electrolyte injection)
------------------------------------------------------------------------
NDA 18-924            Aminophylline in 0.45%    Hospira, Inc.
                       NaCl Injection
------------------------------------------------------------------------
NDA 18-967            Lidocaine HCl and 5%      B. Braun Medical, Inc.
                       Dextrose Injection
------------------------------------------------------------------------
NDA 19-004            Ortho-Novum               Ortho-McNeil
                       (nonrethindrone and       Pharmaceuticals, Inc.,
                       ethinyl estradiol) 7/14-  c/o Johnson & Johnson
                       21 and -28 Tablets        Research and
                                                 Development, L.L.C.
------------------------------------------------------------------------
NDA 19-006            Isolyte S, pH 7.4 (multi- B. Braun Medical, Inc.
                       electrolyte injection)
------------------------------------------------------------------------
NDA 19-025            Isolyte P (multi-
                       electrolyte injection)
                       with 5% Dextrose Do.
------------------------------------------------------------------------
NDA 19-033            Bretylium Tosylate        Hospira, Inc.
                       Injection
------------------------------------------------------------------------
NDA 19-042            Heparin Sodium in NaCl    B. Braun Medical, Inc.
                       Injection
------------------------------------------------------------------------
NDA 19-077            Sterile Water for         Do.
                       Injection USP
------------------------------------------------------------------------

[[Page 10654]]

 
NDA 19-134            Heparin Sodium in 5%      Do.
                       Dextrose Injection
------------------------------------------------------------------------
NDA 19-135            Heparin Sodium in 0.9%    Do.
                       NaCl Injection
------------------------------------------------------------------------
NDA 19-243            Proventil (albuterol      Schering Corp.
                       sulfate) Inhalation
                       Solution
------------------------------------------------------------------------
NDA 19-471            Cardizem SR Capsules      Biovail Laboratories,
                       (diltiazem HCl), 60 mg,   Inc., c/o Biovail
                       90 mg, 120 mg, and 180    Technologies Ltd., 700
                       mg                        Route 202/206 North,
                                                 Bridgewater, NJ 08807-
                                                 0980
------------------------------------------------------------------------
NDA 19-478            Adalat (nifedipine)       Bayer Pharmaceuticals
                       Capsules                  Corp., 400 Morgan Lane,
                                                 West Haven, CT 06516-
                                                 4175
------------------------------------------------------------------------
NDA 19-604            Volmax (albuterol         Muro Pharmaceuticals,
                       sulfate) Extended-        Inc., 890 East St.,
                       Release Tablets           Tewksbury, MA 01876-
                                                 1496
------------------------------------------------------------------------
NDA 19-616            Penetrex (enoxacin)       Aventis Pharmaceuticals,
                       Tablets                   Inc.
------------------------------------------------------------------------
NDA 19-698            Toradol (ketorolac        Roche Palo Alto, LLC, c/
                       tromethamine) Injection   o Hoffman-La Roche,
                                                 Inc., 340 Kingsland
                                                 St., Nutley, NJ 07110
------------------------------------------------------------------------
NDA 19-817            Persantine                Boehringer Ingleheim
                       (dipyridamole)            Pharmaceuticals, Inc.,
                       Injection                 900 Ridgebury Rd., P.O.
                                                 Box 368, Ridgefield, CT
                                                 06877-0368
------------------------------------------------------------------------
NDA 19-978            Bupivacaine HCl           Hospira, Inc.
                       Injection USP
------------------------------------------------------------------------
NDA 20-542            Dopamine HCl in 5%        Do.
                       Dextrose Injection
------------------------------------------------------------------------
NDA 20-677            Zagam (sparfloxacin)      Mylan Pharmaceuticals,
                       Tablets, 200 mg           Inc., 781 Chestnut
                                                 Ridge Rd., P.O. Box
                                                 4310, Morgantown, WV
                                                 26504-4310
------------------------------------------------------------------------
NDA 20-755            Caverject (alprostadil)   Pfizer, Inc., 7000
                       Injection                 Portage Rd., Kalamazoo,
                                                 MI 49001
------------------------------------------------------------------------
NDA 20-942            Versed (midazolam HCl)    Hoffman-La Roche, Inc.
                       Syrup, 2 mg/mL
------------------------------------------------------------------------
NDA 20-997            Chirocaine                Purdue Pharma L.P., One
                       (levobupivacaine HCl)     Stamford Forum,
                       Injection                 Stamford, CT 06901-3431
------------------------------------------------------------------------
NDA 50-010            Ilosone (erythromycin     Eli Lilly & Co.
                       estolate oral
                       suspension) Liquid
------------------------------------------------------------------------
NDA 50-011            Pathocil (dicloxacillin   Wyeth Pharmaceuticals,
                       sodium) Capsules          P.O. Box 8299,
                                                 Philadelphia, PA 19101-
                                                 8299
------------------------------------------------------------------------
NDA 50-199            Unipen (nafcillin         Do.
                       sodium) Powder for Oral
                       Solution
------------------------------------------------------------------------
NDA 50-271            Achromycin (tetracycline  Lederle, c/o Wyeth
                       HCl) Powder for           Pharmaceuticals, P.O.
                       Reconstitution            Box 8299, Philadelphia,
                                                 PA 19101-8299
------------------------------------------------------------------------
NDA 50-320            Unipen (nafcillin         Wyeth Pharmaceuticals
                       sodium) Injection
------------------------------------------------------------------------
NDA 50-365            Ilosone (erythromycin     Eli Lilly & Co.
                       estolate USP) Pulvules
------------------------------------------------------------------------
NDA 50-369            Ilotycin (erythromycin)   Do.
                       Tablets
------------------------------------------------------------------------
NDA 50-426            Ilosone (erythromycin     Do.
                       estolate USP) Tablets
------------------------------------------------------------------------
NDA 50-427            Minocin (minocycline      Lederle, c/o Wyeth
                       HCl) Diagnostic           Pharmaceuticals
                       Susceptibility Powder
------------------------------------------------------------------------
NDA 50-437            Garamycin (gentamicin     Schering Corp.
                       sulfate) Injection, 10
                       mg/mL
------------------------------------------------------------------------
NDA 50-462            Unipen (nafcillin         Wyeth Pharmaceuticals
                       sodium) Tablets
------------------------------------------------------------------------
NDA 50-505            Garamycin (gentamicin     Schering Corp.
                       sulfate) Injection, 2
                       mg/mL
------------------------------------------------------------------------
NDA 50-549            Mezlin (mezlocillin       Bayer Pharmaceuticals
                       sodium monohydrate)       Corp.
                       Sterile Powder for
                       Injection
------------------------------------------------------------------------

[[Page 10655]]

 
ANDA 60-134           Ledercillin VK            Lederle Laboratories,
                       (penicillin V             Pearl River, NY 10965
                       potassium) Tablets, 250
                       mg and 500 mg
------------------------------------------------------------------------
ANDA 60-136           Ledercillin VK            Do.
                       (penicillin V
                       potassium) for Oral
                       Suspension, 125 mg/5 mL
                       and 250 mg/5 mL
------------------------------------------------------------------------
ANDA 60-413           Penicillin G Potassium    Wyeth Laboratories
                       Tablets
------------------------------------------------------------------------
ANDA 60-431           Ilosone (erythromycin     Lilly Research
                       estolate USP) Chewable    Laboratories, Lilly
                       Tablets                   Corporate Center,
                                                 Indianapolis, IN 46285
------------------------------------------------------------------------
ANDA 60-559           Ilosone (erythromycin     Do.
                       estolate) Oral
                       Suspension Liquid
------------------------------------------------------------------------
ANDA 60-625           Omnipen (ampicillin for   Wyeth Laboratories
                       oral suspension USP)
                       for Oral Suspension
------------------------------------------------------------------------
ANDA 60-626           Omnipen-N (ampicillin     Do.
                       sodium) Injection, 125
                       mg, 250 mg, 500 mg, 1
                       gram (g), and 2 g/vial
------------------------------------------------------------------------
ANDA 61-655           Kantrex (kanamycin        Apothecon, c/o Bristol-
                       sulfate) Injection        Myers Squibb Co.
------------------------------------------------------------------------
ANDA 61-675           Wyamycin S (erythromycin  Wyeth Laboratories
                       stearate tablets USP),
                       250 mg and 500 mg
------------------------------------------------------------------------
ANDA 61-685           Tetracycline HCl          Do.
                       Capsules USP, 250 mg
                       and 500 mg
------------------------------------------------------------------------
ANDA 61-769           Cephapirin for Injection  Apothecon, c/o Bristol-
                       USP                       Myers Squibb Co.
------------------------------------------------------------------------
ANDA 61-893           Ilosone (erythromycin     Dista, c/o Lilly
                       estolate USP) for Oral    Research Laboratories,
                       Suspension                Lilly Corporate Center,
                                                 Indianapolis, IN 46285
------------------------------------------------------------------------
ANDA 61-894           Ilosone (erythromycin     Do.
                       estolate) Oral
                       Suspension
------------------------------------------------------------------------
ANDA 61-895           Ilosone (erythromycin     Do.
                       estolate USP) Chewable
                       Tablets
------------------------------------------------------------------------
ANDA 61-896           Ilosone (erythromycin     Do.
                       estolate USP) Tablets
------------------------------------------------------------------------
ANDA 61-897           Ilosone (erythromycin     Do.
                       estolate USP) Pulvules
------------------------------------------------------------------------
ANDA 61-910           Ilotycin (erythromycin)   Do.
                       Enteric Coated Tablets
------------------------------------------------------------------------
ANDA 62-123           Wyamycin E (erythromycin  Wyeth Laboratories
                       ethylsuccinate) Oral
                       Suspension, 200 mg/5 mL
                       and 400 mg/5 mL
------------------------------------------------------------------------
ANDA 62-131           Wymox (amoxicillin) for   Do.
                       Oral Suspension
------------------------------------------------------------------------
ANDA 62-501           Gentacidin Ophthalmic     Novartis Ophthalmics,
                       Ointment (gentamicin      Inc., 11695 John Creek
                       sulfate ophthalmic        Pkwy., Duluth, GA 30097-
                       ointment USP) 0.3%        1523
------------------------------------------------------------------------
ANDA 62-544           Dexacidin (neomycin       Novartis Pharmaceuticals
                       sulfate, polymyxin B      Corp., One Health
                       sulfate, and              Plaza, Building 105
                       dexamethasone)            Eisenhower, East
                       Ophthalmic Suspension     Hanover, NJ 07936
------------------------------------------------------------------------
ANDA 62-566           Dexacidin (neomycin       Novartis Ophthalmics,
                       sulfate, polymyxin B      Inc.
                       sulfate, and
                       dexamethasone)
                       Ophthalmic Ointment
------------------------------------------------------------------------
ANDA 62-717           Unipen (nafcillin         Wyeth Laboratories
                       sodium) Injection, 500-
                       mg, 1-g, and 2-g vials
------------------------------------------------------------------------
ANDA 62-718           Omnipen-N (ampicillin     Do.
                       sodium) Injection, 125-
                       mg, 250-mg, 500-mg, 1-
                       g, and 2-g vials
------------------------------------------------------------------------
ANDA 62-726           Kenamycin Sulfate         Apothecon, c/o Bristol-
                       Capsules USP, 500 mg      Myers Squibb Co.
------------------------------------------------------------------------
ANDA 62-986           Cephalexin For Oral       Do.
                       Suspension USP, 125 mg/
                       5 mL
------------------------------------------------------------------------
ANDA 63-107           Emgel (erythromycin)      GlalxoSmithKline
                       Topical Gel, 2%           Consumer Healthcare,
                                                 L.P., 1500 Littleton
                                                 Rd., Parsippany, NJ
                                                 07054-3884
------------------------------------------------------------------------

[[Page 10656]]

 
ANDA 71-159           Nitro-Bid                 Aventis Pharmaceuticals,
                       (nitroglycerin)           Inc.
                       Injection, 10 mg/mL
------------------------------------------------------------------------
ANDA 74-194           Loperamide HCl Tablets,   L. Perrigo Co., 515
                       2 mg                      Eastern Ave., Allegan,
                                                 MI 49010
------------------------------------------------------------------------
ANDA 74-539           Tamoxifen Citrate         Pharmachemie B.V., c/o
                       Tablets USP, 10 mg        Teva Pharmaceuticals,
                                                 1090 Horsham Rd., P.O.
                                                 Box 1090, North Wales,
                                                 PA 19454-1090
------------------------------------------------------------------------
ANDA 75-114           Acyclovir Injection, 50   Abbott Laboratories
                       mg/mL
------------------------------------------------------------------------
ANDA 75-583           Enalapril Maleate         Apothecon Inc., c/o
                       Tablets USP, 2.5 mg, 5    Bristol-Myers Squibb
                       mg, 10 mg, and 20 mg      Co.
------------------------------------------------------------------------
ANDA 75-729           Famotidine Injection,     Abbott Laboratories
                       0.4 mg/mL
------------------------------------------------------------------------
ANDA 76-214           Sotalol HCl Tablets, 80   TorPharm, c/o Apotex
                       mg, 120 mg, and 160 mg    Corp., 616 Heathrow
                                                 Dr., Lincolnshire, IL
                                                 60069
------------------------------------------------------------------------
ANDA 83-823           Nicolar (niacin)          Aventis Pharmaceuticals,
                       Tablets, 500 mg           Inc.
------------------------------------------------------------------------
ANDA 83-892           Selenium Sulfide Lotion   Allergan, 2525 Dupont
                       USP                       Dr., P.O. Box 19534,
                                                 Irvine, CA 92623
------------------------------------------------------------------------
ANDA 84-476           Domeboro (acetic acid,
                       glacial and aluminum
                       acetate) SolutionBayer
                       Pharmaceuticals Corp.
------------------------------------------------------------------------
ANDA 85-113           Chlordiazepoxide HCl      Impax Laboratories,
                       Capsules USP, 10 mg       Inc., 30831 Huntwood
                                                 Ave., Hayward, CA 94544
------------------------------------------------------------------------
ANDA 85-187           Slo-Phyllin               Aventis Pharmaceuticals,
                       (theophylline) Syrup,     Inc.
                       80 mg/15 mL
------------------------------------------------------------------------
ANDA 85-202           Slo-Phyllin               Do.
                       (theophylline) Tablets,
                       100 mg
------------------------------------------------------------------------
ANDA 85-204           Slo-Phyllin               Do.
                       (theophylline) Tablets,
                       200 mg
------------------------------------------------------------------------
ANDA 86-126           Nitrong SR                Do.
                       (nitroglycerin)
                       Tablets, 6.5 mg
------------------------------------------------------------------------
ANDA 86-137           Nitrong (nitroglycerin)   Do.
                       Ointment, 2%
------------------------------------------------------------------------
ANDA 86-138           Nitrong (nitroglycerin)   Do.
                       Tablets, 2.6 mg
------------------------------------------------------------------------
ANDA 86-681           Acetaminophen and         Purepac Pharmaceutical
                       Codeine Phospate          Co., 200 Elmora Ave.,
                       Tablets USP, 300 mg/30    Elizabeth, NJ 07207
                       mg
------------------------------------------------------------------------
ANDA 87-715           Nitrong SR                Do.
                       (nitroglycerin)
                       Tablets, 9 mg
------------------------------------------------------------------------
ANDA 87-892           Slo-Bid (theophylline)    Aventis Pharmaceuticals,
                       Capsules, 100 mg          Inc.
------------------------------------------------------------------------
ANDA 87-893           Slo-Bid (theophylline)    Do.
                       Capsules, 200 mg
------------------------------------------------------------------------
ANDA 87-894           Slo-Bid (theophylline)    Do.
                       Capsules, 300 mg
------------------------------------------------------------------------
ANDA 88-082           Hydrocortisone USP,       Paddock Laboratories,
                       Micronized Powder         Inc., 3940 Quebec Ave.
                       (Nonsterile)              South, Minneapolis, MN
                                                 55427
------------------------------------------------------------------------
ANDA 88-269           Slo-Bid (theophylline)    Aventis Pharmaceuticals,
                       Capsules, 50 mg           Inc.
------------------------------------------------------------------------
ANDA 88-782           NTS 5 (nitroglycerin)     Hercon Laboratories
                       Transdermal Systems       Corp., 101 Sinking
                                                 Springs Lake, P.O. Box
                                                 467, Emigsville, PA
                                                 17318
------------------------------------------------------------------------
ANDA 88-783           NTS 15 (nitroglycerin)    Do.
                       Transdermal Systems
------------------------------------------------------------------------
ANDA 88-791           Vasocidin (sulfacetamide  Novartis Ophthalmics,
                       sodium and prednisolone   Inc.
                       acetate) Ophthalmic
                       Ointment
------------------------------------------------------------------------
ANDA 89-047           Sulf-15 (sulfacetamide    Do.
                       sodium ophthalmic
                       solution USP), 15%
------------------------------------------------------------------------
ANDA 89-516           NTS 10 (nitroglycerin)    Hercon Laboratories
                       Transdermal Systems       Corp.
------------------------------------------------------------------------
ANDA 89-539           Slo-Bid (theophylline)    Aventis Pharmaceuticals,
                       Capsules, 75 mg           Inc.
------------------------------------------------------------------------
ANDA 89-540           Slo-Bid (theophylline)    Do.
                       Capsules, 125 mg
------------------------------------------------------------------------


[[Page 10657]]

    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, 
approval of the applications listed in the table in this document, and 
all amendments and supplements thereto, is hereby withdrawn, effective 
April 4, 2005.

    Dated: January 31, 2005.
Steven Galson,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 05-4158 Filed 3-3-05; 8:45 am]
BILLING CODE 4160-01-S