[Federal Register Volume 65, Number 178 (Wednesday, September 13, 2000)]
[Pages 55264-55265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23477-Filed]



Food and Drug Administration

[Docket No. 00N-1498]

Lilly Research Laboratories et al.; Withdrawal of Approval of 28 
New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 28 new drug applications (NDA'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 

DATES: Effective September 30, 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.

[[Page 55265]]

     Application No.                       Drug                                      Applicant
NDA 4-038                 Diethylstilbestrol (DES) Injection.     Lilly Research Laboratories, Lilly Corporate
                                                                   Center, Indianapolis, IN 46285.
NDA 4-039                 DES Tablets.                            Do.
NDA 4-040                 DES Suppository.                        Do.
NDA 4-041                 DES Tablets.                            Do.
NDA 4-056                 Stilbetin Tablets (Diethylstilbestrol   Bristol-Myers Squibb Co., P.O. Box 4000,
                           Tablets USP).                           Princeton, NJ 08543-4000.
NDA 6-327                 Isuprel (Isoproterenol Hydrochloride)   Sanofi-Synthelabo, Inc., 90 Park Ave., New
                           Inhalation Solution.                    York, NY 10016-1389.
NDA 7-371                 Mecostrin Injection (Dimethyl           Bristol-Myers Squibb Co.
                           Tubocurarine Chloride).
NDA 8-392                 Nydrazid (Isoniazid USP) Tablets,       Do.
                           Syrup, Capsules.
NDA 9-052                 Rezipas (Aminosalicylic Acid Resin      Do.
NDA 9-273                 Rauwolfia Serpentina, 50-milligram      Impax Laboratories, Inc., 30831 Huntwood Ave.,
                           (mg) and 100-mg Tablets, 35-mg          Hayward, CA 94544.
NDA 9-627                 Reserpine, 0.1-mg, 0.25-mg, 0.5-mg,     Do.
                           and 1-mg Tablets.
NDA 10-010                Stilphostrol (Diethylstilbestrol        Bayer Corp., 400 Morgan Lane, West Haven, CT
                           Diphosphate) Injection and Tablets.     06516-4175.
NDA 10-347                Delalutin (Hydroxyprogesterone          Bristol-Myers Squibb Co.
                           Caproate Injection USP).
NDA 11-359                Ora-testryl (Fluoxymesterone Tablets    Do.
NDA 11-642                Cardioquin (Quinidine                   Purdue Frederick Co., 100 Connecticut Ave.,
                           Polygalacturonate) 275-mg Tablets.      Norwalk, CT 06850-3590.
NDA 11-745                Konakion (Phytonadione) Injection.      Hoffman-La Roche, Inc., 340 Kingsland St.,
                                                                   Nutley, NJ 07110.
NDA 12-248                Plegine (Phendimetrazine Tartate)       Wyeth Ayerst Laboratories, P.O. Box 8299,
                           Tablets.                                Philadelphia, PA 19101-8299.
NDA 12-339                Bronkometer (Isoetharine Mesylate       Sanofi-Synthelabo, Inc.
                           Inhalation Aerosol) and Bronkosol
                           (Isoetharine Hydrochloride Inhalation
NDA 16-911                Delalutin (Hydroxyprogesterone          Bristol-Myers Squibb Co.
                           Caproate Injection USP).
NDA 17-424                Septisol Foam (Hexachlorophene).        Steris Corp., P.O. Box 147, St. Louis, MO
NDA 18-672                Nitro IV 5 mg/milliliters (mL)          G. Pohl-Boskamp GmbH & Co., Kieler Strasse 11,
                           Injection and Nitronal Injection.       D-25551 Hohenlockstedt, Germany.
NDA 18-762                Brethaire (Terbutaline Sulfate)         Novartis Pharmaceuticals Corp., 59 Route 10,
                           Inhalation Aerosol.                     East Hanover, NJ 07936-1080.
NDA 19-069                Mycelex (Clotrimazole) Vaginal          Bayer Corp.
NDA 19-082                Dalgan (Dezocine) Injection, 5, 10,     AstraZeneca LP, 725 Chesterbrook Blvd., Wayne,
                           and 15 mg/mL.                           PA 19087-5677.
NDA 19-174                Trandate HCT (Labetalol Hydrochloride/  Glaxo Wellcome, Inc., P.O. Box 13398, Research
                           Hydrochlorothiazide) Tablets.           Triangle Park, NC 27709.
NDA 19-287                DIZAC (Diazepam Injectable Emulsion).   Pharmacia & Upjohn, 7000 Portage Rd.,
                                                                   Kalamazoo, MI 49001-0199.
NDA 20-559                Tritec (Ranitidine Bismuth Citrate)     Glaxo Wellcome, Inc.
NDA 21-048                17-Estradiol Transdermal       R. W. Johnson Pharmaceutical Research
                           System.                                 Institute, 920 Route 202 South, P.O. Box 300,
                                                                   Raritan, NJ 08869-0602.

    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 
September 30, 2000.

    Dated: September 5, 2000.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 00-23477-Filed 9-12-00; 8:45 am]