[Federal Register Volume 65, Number 54 (Monday, March 20, 2000)]
[Notices]
[Pages 14983-14985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6722]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-0988]


Lilly Research Laboratories et al.; Withdrawal of Approval of 22 
New Drug Applications and 36 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 22 new drug applications (NDA's) and 36 abbreviated new drug 
applications (ANDA's). 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requested that the approval of the applications be withdrawn.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 April 19, 2000.

FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, 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 request, waived 
their opportunity for a hearing.

 
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       Application No.                                    Drug                                                        Applicant
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NDA 6-139                     Surfacaine (cyclomethycaine).                                 Lilly Research Laboratories, Lilly Corporate Center,
                                                                                             Indianapolis, IN 46285.
NDA 6-904                     Terfonyl (trisulfapyrimidines) Tablets and Oral Suspension.   Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-
                                                                                             4000.
NDA 9-357                     Rau-Sed (reserpine) Tablets.                                  Do.
NDA 9-523                     Tyzine 0.1% (tetrahydrozoline HCl).                           Pfizer, Inc., 235 East 42d St., New York, NY 10017-5755.
NDA 9-941                     Tyzine 0.05% (tetrahydrozoline HCl) Pediatric Nasal Drops.    Do.
NDA 10-520                    Leritine (anileridine HCl) Injection                          Merck & Co., Inc., P.O. Box 4, BLA-20, West Point, PA 19486.
NDA 11-028                    Hydeltrasol (prednisolone sodium phosphate) Sterile           Do.
                               Ophthalmic Ointment, 0.25%.
NDA 11-178                    Isuprel (isoproterenol hydrochloride) Mistometer.             Sanofi Winthrop, Inc., 90 Park Ave., New York, NY 10016-
                                                                                             1389.
NDA 11-602                    Kenalog (triamcinolone acetonide) Lotion.                     Bristol-Myers Squibb Co.
NDA 12-335                    Forhistal (dimethindene maleate) Tablets.                     Novartis Pharmaceuticals Corp., 59 Route 10, East Hanover,
                                                                                             NJ 07936-1080.
NDA 12-337                    Forhistal (dimethindene maleate) Syrup.                       Do.
NDA 12-338                    Forhistal (dimethindene maleate) Pediatric Drops.             Do.
NDA 16-755                    Diapid (Lypressin Nasal Solution USP) Nasal Spray.            Novartis Pharmaceuticals Corp.
NDA 16-990                    Intal (Cromolyn Sodium for Inhalation USP) Capsules.          Rhone-Poulenc Rorer Pharmaceuticals, Inc., 500 Arcola Rd.,
                                                                                             P.O. Box 1200, Collegeville, PA 19426-0107.
NDA 17-605                    Xylo-Pfan (Xylose USP) Powder.                                Savage Laboratories, 60 Baylis Rd., Melville, NY 11747.
NDA 19-215                    FEMSTAT (butoconazole nitrate) 2% Vaginal Cream               Hoffmann-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-
                               (prescription).                                               1199.
NDA 19-359                    FEMSTAT (butoconazole nitrate) Suppositories, 100 milligrams  Do.
                               (mg).

[[Page 14984]]

 
NDA 20-750                    Tilade (nedocromil sodium inhalation solution) Nebulizer      Rhone-Poulenc Rorer Pharmaceuticals, Inc.
                               Solution.
NDA 50-128                    Bicillin (penicillin G benzathine) Tablets.                   Wyeth-Ayerst Laboratories, P.O. Box 8299, Philadelphia, PA
                                                                                             19101-8299.
NDA 50-306                    GEOPEN (carbenicillin disodium) IM/IV.                        Pfizer, Inc.
NDA 50-318                    Kenalog-S Nasal Spray (neomycin sulfate-gramicidin and        Bristol-Myers Squibb Co.
                               triamcinolone acetonide with phenylephrine)
NDA 50-518                    Meclan (meclocycline sulfosalicylate) Cream, 1%.              Johnson & Johnson Consumer Companies, Inc., 199 Grandview
                                                                                             Rd., Skillman, NJ 08558-9418.
ANDA 60-124                   Strycin (streptomycin) Syrup.                                 Bristol-Myers Squibb Co.
ANDA 60-513                   Streptomycin Sulfate Injection USP.                           Do.
ANDA 60-933                   Spectrocin (Neomycin Sulfate and Gramicidin Ointment USP).    Do.
ANDA 61-523                   Achromycin (tetracycline HCl) Diagnostic Susceptibility       Wyeth-Ayerst Laboratories.
                               Powder, 20 mg.
ANDA 61-605                   ETHRIL (Erythromycin Stearate Tablets USP).                   Bristol-Myers Squibb Co.
ANDA 62-224                   Neomycin Sulfate Ointment USP.                                Do.
ANDA 62-305                   Pediamycin Suspension and Pediamycin Oral Drops               Abbot Laboratories, 100 Abbott Park Rd., D-491, AP6B-1SW,
                               (erythromycin ethylsuccinate for oral suspension).            Abbott Park, IL 60064-6108.
ANDA 62-306                   Erythromycin Ethylsuccinate Tablets, 200 mg.                  Do.
ANDA 62-334                   Cefadroxil for Oral Suspension USP.                           Apothecon, Inc., A Bristol-Myers Squibb Co., P.O. Box 4500,
                                                                                             Princeton, NJ 08543-4500.
ANDA 62-390                   Cifadroxil Tablets USP, 1 gram (g).                           Do.
ANDA 62-818                   Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic   Fujisawa Healthcare, Inc., 3 Parkway North Center Deerfield,
                               Solution.                                                     IL 60015-2548.
ANDA 64-026                   Tobramycin Sulfate Injection USP, 40 mg/mL.                   Apothecon, Inc.
ANDA 71-151                   Bretylium Tosylate Injection.                                 AstraZeneca, 725 Chesterbrook Blvd., Wayne, PA 19087-5677.
ANDA 71-153                   Bretylium Tosylate Injection.                                 Do.
ANDA 71-319                   Naproxen Sodium Tablets USP.                                  Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ
                                                                                             07207.
ANDA 74-360                   Gemfibrozil Tablets USP, 600 mg.                              Do.
NDA 74-380                    Metoprolol Tartrate Tablets USP, 50 mg and 100 mg.            Do.
ANDA 74-658                   Acyclovir Tablets USP, 400 and 800 mg.                        Lek Pharmaceutical and Chemical Co. d.d., c/o Lek USA, Inc.,
                                                                                             333 Sylvan Ave., Englewood Cliffs, NJ 07632.
ANDA 74-750                   Acyclovir Capsules USP, 200 mg.                               Do.
ANDA 75-516                   Serecon Eye Drops (pheniramine maleate and naphazoline HCl    Optikem International, Inc., c/o Medvice Consulting, Inc.,
                               ophthalmic solution), 0.315%/0.02675%.                        623 Glacier Dr., Grand Junction, CO 81503.
ANDA 80-321                   Prednisone Tablets USP, 5 mg.                                 Vintage Pharmaceuticals, Inc., 3241 Woodpark Blvd.
                                                                                             Charlotte, NC 28206.
ANDA 80-322                   Prednisolone Tablets USP, 5 mg.                               Do.
ANDA 80-860                   Vitamin A Capsules USP                                        Bristol-Myers Squibb Co.
ANDA 83-807                   Prednisolone Tablets USP, 20 mg.                              Vintage Pharmaceuticals, Inc.
ANDA 84-627                   Quinidine Sulfate Tablets USP, 200 mg.                        Pharmavite Corp., P.O. Box 9606, Mission Hills, CA 91346-
                                                                                             9606.
ANDA 85-147                   Quinidine Sulfate Tablets USP, 200 mg.                        Jones Pharma, Inc., 1945 Craig Rd., P.O. Box 46903, St.
                                                                                             Louis, MO 63146.
ANDA 85-150                   Diphenhydramine HCl Capsules USP, 50 mg.                      Purepac Pharmaceutical Co.
ANDA 85-156                   Diphenhydramine HCl Capsules USP, 25 mg.                      Do.
ANDA 85-665                   Austaire (theophylline anhydrous) Tablets.                    Pfizer, Inc.
ANDA 86-454                   AMITID Tablets (Amitriptyline HCl Tablets USP).               Bristol-Myers Squibb Co.
ANDA 86-569                   Theoclear L.A.-130 and Theoclear L.A.-260 (theophylline       Schwarz Pharma, Inc., 5600 West County Line Rd., Mequon, WI
                               extended-release capsules, 130 mg and 260 mg).                53092.
ANDA 87-073                   MD-76 (Diatrizoate Meglumine and Diatrizoate Sodium           Mallinckrodt, Inc., 675 McDonnell Blvd., P.O. Box 5840, St.
                               Injection USP, 66%/10%).                                      Louis, MO 63134.
ANDA 88-758                   Butalbital, Acetaminophen, and Caffeine Capsules USP, 50 mg/  Mallinckrodt Chemical, Inc., P.O. Box P, 58 Pearl St.,
                               325 mg/40 mg.                                                 Hobart, NY 13788-0416.
ANDA 89-023                   TRIAD (Butalbital, Acetaminophen, and Caffeine Capsules       Do.
                               USP), 50 mg/325 mg/40 mg.
ANDA 89-102                   FEMCET (Butalbital, Acetaminophen, and Caffeine Capsules      Do.
                               USP), 50 mg/325 mg/40 mg.
ANDA 89-426                   Dipyridamole Tablets USP, 50 mg.                              Purepac Pharmaceutical Co.
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[[Page 14985]]

    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 (21 CFR 5.82), 
approval of the applications listed in the table in this document, and 
all amendments and supplements thereto, is hereby withdrawn, effective 
April 19, 2000.

    Dated: March 7, 2000.
Janet A. Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 00-6722 Filed 3-17-00; 8:45 am]
BILLING CODE 4160-01-F