[Federal Register Volume 68, Number 159 (Monday, August 18, 2003)]
[Notices]
[Pages 49481-49488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20949]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0335]


Eli Lilly and Co. et al.; Withdrawal of Approval of 80 New Drug 
Applications and 75 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

[[Page 49482]]

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 80 new drug applications (NDAs) and 75 abbreviated new drug 
applications (ANDAs). 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requested that the approval of the applications be withdrawn.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: September 17, 2003

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 0-159                Sulfapyridine Tablets.   Eli Lilly and Co.,
                                                   Lilly Corporate
                                                   Center, Indianapolis,
                                                   IN 46285.
------------------------------------------------------------------------
NDA 0-734                Histamine Phosphate      Do.
                          Injection.
------------------------------------------------------------------------
NDA 5-970                Sotradecol (sodium       Wyeth Pharmaceuticals,
                          tetradecyl sulfate)      P.O. Box 8299,
                          Injection.               Philadelphia, PA
                                                   19101-8299.
------------------------------------------------------------------------
NDA 7-898                Benemid (probenecid)     Merck & Co., Inc.,
                          Tablets.                 Sunneytown Pike, P.O.
                                                   Box 4, BLA-20, West
                                                   Point, PA 19486.
------------------------------------------------------------------------
NDA 8-048                Xylocaine (lidocaine)    AstraZeneca
                          Ointment.                Pharmaceuticals LP,
                                                   1800 Concord Pike,
                                                   P.O. Box 8355,
                                                   Wilmington, DE 19803-
                                                   8355.
------------------------------------------------------------------------
NDA 8-228                Hydrocortone             Merck & Co., Inc.
                          (hydrocortisone
                          acetate) Acetate
                          Injectable Suspension.
------------------------------------------------------------------------
NDA 8-565                Thiosulfil               Wyeth Pharmaceuticals.
                          (sulfamethizole)
                          Tablets and
                          Suspension.
------------------------------------------------------------------------
NDA 9-489                Pathilon                 Lederle Laboratories,
                          (tridehixethyl)          P.O. Box 8299,
                          Tablets.                 Philadelphia, PA
                                                   19101-8299.
------------------------------------------------------------------------
NDA 10-210               Metymid Ophthalmic       Schering Corp., 2000
                          (prednisolone acetate    Galloping Hill Rd.,
                          and sulfacetamide        Kenilworth, NJ 07033.
                          sodium).
------------------------------------------------------------------------
NDA 10-220               Hypaque-M 75% and 90%    Amersham Health, 101
                          Hypague Compound         Carnegie Center,
                          (diatrizoate meglumine   Princeton, NJ 08540-
                          and diatrizoate          6231.
                          sodium) Injection.
------------------------------------------------------------------------
NDA 10-348               Sparine (promazine       Wyeth Pharmaceuticals.
                          hydrochloride (HCl))
                          Tablets.
------------------------------------------------------------------------
NDA 10-496               Xylocaine-MPF 5%         AstraZeneca
                          Solution With Glucose    Pharmaceuticals LP.
                          7.5% (lidocaine HCl
                          and dextrose).
------------------------------------------------------------------------
NDA 10-562               Hydeltra-T.B.A.          Merck & Co., Inc.
                          (prednisolone
                          tebutate).
------------------------------------------------------------------------
NDA 10-753               Estradurin               Wyeth Pharmaceuticals.
                          (polyestradiol
                          phosphate) Injection.
------------------------------------------------------------------------
NDA 10-942               Sparine (promazine HCl)  Do.
                          Syrup and Concentrate.
------------------------------------------------------------------------
NDA 11-338               Fluothane Inhalation     Do.
                          (halothane USP).
------------------------------------------------------------------------
NDA 11-418               Dimetane Ten Injectable  Do.
                          (brompheniramine
                          maleate).
------------------------------------------------------------------------
NDA 11-673               Tepanil (diethylpropion  3M Pharmaceuticals, 3M
                          HC1) Tablets.            Center, Bldg. 270-3A-
                                                   01, St. Paul, MN
                                                   55144-1000.
------------------------------------------------------------------------
NDA 11-958               Hydropres (reserpine     Merck & Co., Inc.
                          and
                          hydrochlorothiazide).
------------------------------------------------------------------------
NDA 12-383               ColBenemid (probenecid   Do.
                          and colchicine)
                          Tablets.
------------------------------------------------------------------------
NDA 12-418               Akineton (biperiden      Abbott Laboratories,
                          lactate) Injection.      200 Abbott Park Rd.,
                                                   Abbott Park, IL 60064-
                                                   6157.
------------------------------------------------------------------------
NDA 12-489               Exna (benzthiazide)      Wyeth Pharmaceuticals.
                          Tablets.
------------------------------------------------------------------------

[[Page 49483]]

 
NDA 12-731               Decaspray                Merck & Co., Inc.
                          (dexamethasone)
                          Topical Aerosol.
------------------------------------------------------------------------
NDA 12-882               Isordil Tembids          Wyeth Pharmaceuticals.
                          (isosorbide dinitrate)
                          Controlled-Release
                          Tablets and Capsules.
------------------------------------------------------------------------
NDA 12-947               Artane (trihexyphenidyl  Lederle Laboratories.
                          HCl) Sustained-Release
                          Capsules.
------------------------------------------------------------------------
NDA 13-264               Hydromox (quinethazone)  Wyeth Pharmaceuticals.
                          Tablets.
------------------------------------------------------------------------
NDA 13-334               Decadron With Xylocaine  Merck & Co., Inc.
                          Injection
                          (dexamethasone sodium
                          phosphate and
                          lidocaine HCl).
------------------------------------------------------------------------
NDA 13-378               Dymelor (acetohexamide)  Eli Lilly and Co.
                          Tablets.
------------------------------------------------------------------------
NDA 13-731               Bilopaque (tyropanoate   Amersham Health.
                          sodium) Capsules.
------------------------------------------------------------------------
NDA 14-763               Citanest Plain           AstraZeneca
                          (prilocaine HCl) and     Pharmaceuticals LP.
                          Citanest Forte
                          (prilocaine HCl and
                          epinephrine)
                          Injection.
------------------------------------------------------------------------
NDA 15-052               Atabrine (quinacrine     Abbott Laboratories.
                          HCl) Injection.
------------------------------------------------------------------------
NDA 15-921               Haldol (haloperidol)     Ortho-McNeil
                          Tablets.                 Pharmaceutical, Inc.,
                                                   c/o Johnson & Johnson
                                                   Pharmaceutical
                                                   Research &
                                                   Development, L.L.C.,
                                                   1125 Trenton-
                                                   Harbourton Rd.,
                                                   Titusville, NJ 08560-
                                                   0200.
------------------------------------------------------------------------
NDA 15-922               Haldol (haloperidol      Do.
                          lactate) Oral
                          Concentrate.
------------------------------------------------------------------------
NDA 16-192               Sorbitrate (isosorbide   AstraZeneca
                          dinitrate) Oral 5        Pharmaceuticals LP.
                          milligram (mg) and 10
                          mg Tablets.
------------------------------------------------------------------------
NDA 16-675               Decadron LA              Merck & Co., Inc.
                          (dexamethasone
                          acetate) Sterile
                          Suspension.
------------------------------------------------------------------------
NDA 16-776               Sorbitrate (isosorbide   AstraZeneca
                          dinitrate) Chewable      Pharmaceuticals LP.
                          Tablets.
------------------------------------------------------------------------
NDA 17-048               Peptavlon                Wyeth Pharmaceuticals.
                          (pentagastrin) for
                          Subcutaneous
                          Injection.
------------------------------------------------------------------------
NDA 17-406               Dicopac Kit.             Amersham Health.
------------------------------------------------------------------------
NDA 17-503               Combipres (clonidine     Boehringer Ingelheim
                          HCl and                  Pharmaceuticals,
                          chlorthalidone)          Inc., 900 Ridgebury
                          Tablets.                 Rd., P.O. Box 368,
                                                   Ridgefield, CT 06877-
                                                   0368.
------------------------------------------------------------------------
NDA 17-638               Thypinone (protirelin)   Abbott Laboratories.
                          Injection.
------------------------------------------------------------------------
NDA 17-653               Technetium Tc-99m        Amersham Health.
                          HEDSPA Multidose Kit.
------------------------------------------------------------------------
NDA 17-691               Diprosone                Schering Corp.
                          (betamethasone
                          dipropionate)
                          Ointment, 0.05%.
------------------------------------------------------------------------
NDA 17-751               Duranest (etidocaine     AstraZeneca
                          HCl) Injection.          Pharmaceuticals LP.
------------------------------------------------------------------------
NDA 17-775               Technetium Tc-99m HSA    Medi-Physics, Inc.,
                          Kit.                     d.b.a., Nycomed
                                                   Amersham Imaging, 101
                                                   Carnegie Center,
                                                   Princeton, NJ 08540-
                                                   6231.
------------------------------------------------------------------------
NDA 17-784               Technetium Tc-99m TSC    Amersham Health.
                          Kit.
------------------------------------------------------------------------
NDA 17-980               Mazanor (mazindol)       Wyeth Pharmaceuticals.
                          Tablets.
------------------------------------------------------------------------
NDA 17-982               Amipaque (metrizamide)   Amersham Health.
                          Injection.
------------------------------------------------------------------------
NDA 17-992               Crescormon (somatropin,  Genentech, Inc., 1 DNA
                          pituitary).              Way, MS[numsign]48,
                                                   South San Francisco,
                                                   CA 94080-4990.
------------------------------------------------------------------------
NDA 18-021               Asendin (amoxapine) 25   Wyeth Pharmaceuticals.
                          mg, 50 mg, 100 mg, and
                          150 mg Tablets.
------------------------------------------------------------------------

[[Page 49484]]

 
NDA 18-153               Beclovent                GlaxoSmithKline, Five
                          (beclomethasone          Moore Dr., Research
                          dipropionate)            Triangle Park, NC
                          Inhalation Aerosol.      27709.
------------------------------------------------------------------------
NDA 18-280               Yutopar (ritodrine HCl)  Solvay
                          Tablets and Injection.   Pharmaceuticals,
                                                   Inc., 901 Sawyer Rd.,
                                                   Marietta, GA 30062.
------------------------------------------------------------------------
NDA 18-290               Secretin-Ferring Powder  Ferring
                          for Injection.           Pharmaceuticals,
                                                   Inc., 120 White
                                                   Plains Rd., Suite
                                                   400, Tarrytown, NY
                                                   10591.
------------------------------------------------------------------------
NDA 18-381               Regular Purified Pork    Novo Nordisk
                          Insulin.                 Pharmaceuticals,
                                                   Inc., 100 College Rd.
                                                   West, Princeton, NJ
                                                   08540.
------------------------------------------------------------------------
NDA 18-383               Lente Purified Pork      Do.
                          Insulin Zinc
                          Supension.
------------------------------------------------------------------------
NDA 18-450               Nitropress (sodium       Abbott Laboratories.
                          nitroprusside)
                          Injection.
------------------------------------------------------------------------
NDA 18-623               NPH Purified Pork        Novo Nordisk
                          Isophane Insulin         Pharmaceuticals, Inc.
                          Suspension.
------------------------------------------------------------------------
NDA 19-112               Ventolin (albuterol      GlaxoSmithKline.
                          sulfate) Tablets.
------------------------------------------------------------------------
NDA 19-269               Ventolin (albuterol      Do.
                          sulfate) Inhalation
                          Solution, 0.5%.
------------------------------------------------------------------------
NDA 19-280               Cyklokapron (tranexamic  Pharmacia & Upjohn
                          acid) Tablets.           Co., 7000 Portage
                                                   Rd., Kalamazoo, MI
                                                   49001-0199.
------------------------------------------------------------------------
NDA 19-489               Ventolin (albuterol      GlaxoSmithKline.
                          sulfate) Rotacaps
                          Inhalation Powder.
------------------------------------------------------------------------
NDA 19-536               Inderal (propranolol     Wyeth Pharmaceuticals.
                          HCl) Oral Suspension.
------------------------------------------------------------------------
NDA 19-773               Ventolin (albuterol      GlaxoSmithKline.
                          sulfate) Nebules
                          Inhalation Solution,
                          0.083%.
------------------------------------------------------------------------
NDA 19-836               Supprelin (histrelin     Shire Pharmaceutical
                          acetate) Injection.      Development, Inc.,
                                                   1801 Research Blvd.,
                                                   Suite 600, Rockville,
                                                   MD 20850.
------------------------------------------------------------------------
NDA 20-063               Technetium Tc-99m Red    Cadema Corp., c/o
                          Blood Cell Kit.          Number One
                                                   Corporation, 50
                                                   Washington St.,
                                                   Norwalk, CT 06854.
------------------------------------------------------------------------
NDA 20-924               Cernevit-12              Baxter Healthcare
                          Multivitamins.           Corp., Route 120 and
                                                   Wilson Rd., RLT-10,
                                                   Round Lake, IL 60073-
                                                   0490.
------------------------------------------------------------------------
NDA 21-384               Duranest (etidocaine     Dentsply
                          HCl and epinephrine      Pharmaceutical, 3427
                          bitartrate) Injection.   Concord Rd., York, PA
                                                   17402.
------------------------------------------------------------------------
NDA 50-202               Chloromycetin            Parkdale
                          Hydrocortisone           Pharmaceuticals,
                          Ophthalmic               Inc., 501 Fifth St.,
                          (chloramphenicol and     Bristol, TN 37620.
                          hydrocortisone acetate
                          for ophthalmic
                          suspension USP).
------------------------------------------------------------------------
NDA 50-251               Aureomycin               Wyeth Pharmaceuticals.
                          (chlortetracycline
                          HCl) Capsules.
------------------------------------------------------------------------
NDA 50-257               Declomycin               Do.
                          (demeclocycline HCl)
                          Syrup Drops.
------------------------------------------------------------------------
NDA 50-263               Achromycin V             Do.
                          (tetracycline HCl)
                          Suspension and Drops.
------------------------------------------------------------------------
NDA 50-264               Achromycin               Do.
                          (tetracycline HCl).
------------------------------------------------------------------------
NDA 50-315               Minocin (minocycline     Do.
                          HCl) Capsules.
------------------------------------------------------------------------
NDA 50-451               Minocin (minocycline     Do.
                          HCl) Tablets.
------------------------------------------------------------------------
NDA 50-483               Nebcin (tobramycin       Eli Lilly and Co.
                          sulfate) Sensitivity
                          Disk.
------------------------------------------------------------------------
NDA 50-484               Cerubidine               Wyeth Pharmaceuticals.
                          (daunorubicin HCl)
                          Injection.
------------------------------------------------------------------------
NDA 50-493               Topicycline              Shire Pharmaceutical
                          (tetracycline HCl)       Development, Inc.
                          Solution.
------------------------------------------------------------------------

[[Page 49485]]

 
NDA 50-508               Cyclapen-W               Wyeth Pharmaceuticals.
                          (cyclacillin) Oral
                          Suspension.
------------------------------------------------------------------------
NDA 50-509               Cyclapen-W               Do.
                          (cyclacillin) Tablets.
------------------------------------------------------------------------
NDA 50-544               Netromycin (netilmicin   Schering Corp.
                          sulfate) Injection.
------------------------------------------------------------------------
NDA 50-633               Cefpiramide Sodium       Wyeth Pharmaceuticals.
                          Injection.
------------------------------------------------------------------------
ANDA 60-007              Pen-Vee K for Oral       Do.
                          Solution (penicillin V
                          potassium for oral
                          solution), 125 mg
                          (base)/5 milliliters
                          (mL) and 250 mg (base)/
                          5 mL.
------------------------------------------------------------------------
ANDA 60-462              Garamycin (gentamicin    Schering Corp.
                          sulfate) Cream, 0.1%.
------------------------------------------------------------------------
ANDA 61-151              Nilstat (nystatin)       Lederle Laboratories.
                          tablets USP) Oral
                          Tablets, 500,000
                          units.
------------------------------------------------------------------------
ANDA 61-325              Nilstat (nystatin)       Do.
                          Vaginal Tablets,
                          100,000 units.
------------------------------------------------------------------------
ANDA 61-444              Nilstat (nystatin)       Do.
                          Ointment, 100,000
                          units/gram (g).
------------------------------------------------------------------------
ANDA 61-445              Nilstat (nystatin)       Do.
                          Cream, 100,000/g.
------------------------------------------------------------------------
ANDA 61-633              Robimycin                A.H. Robins Co., P.O.
                          (erythromycin)           Box 8299,
                          Robitabs, 250 mg.        Philadelphia, PA
                                                   19101-8299.
------------------------------------------------------------------------
ANDA 61-734              Robitet (tetracycline    Wyeth Pharmaceuticals.
                          HCl capsules USP)
                          Robicaps, 250 mg and
                          500 mg.
------------------------------------------------------------------------
ANDA 62-120              Wymox (amoxicillin)      Do.
                          Capsules, 250 mg and
                          500 mg.
------------------------------------------------------------------------
ANDA 62-302              Otobiotic (polymyxin B   Schering Corp.
                          sulfate and
                          hydrocortisone otic
                          solution USP) Sterile
                          Otic Solution.
------------------------------------------------------------------------
ANDA 62-579              Precef (ceforanide) for  Apothecon, c/o Bristol-
                          Injection.               Myers Squibb Co.,
                                                   P.O. Box 4500,
                                                   Princeton, NJ 08543-
                                                   4500.
------------------------------------------------------------------------
ANDA 62-821              Cephalexin Capsules      TEVA Pharmaceutical
                          USP, 250 mg.             USA, 1090 Horsham
                                                   Rd., P.O. Box 1090,
                                                   North Wales, PA
                                                   19454.
------------------------------------------------------------------------
ANDA 62-823              Cephalexin Capsules      TEVA Pharmaceutical
                          USP, 500 mg.             USA.
------------------------------------------------------------------------
ANDA 62-860              Ampicillin for           Apothecon.
                          Injection.
------------------------------------------------------------------------
ANDA 62-867              Cephalexin for Oral      TEVA Pharmaceutical
                          Suspension USP, 250 mg/  USA.
                          5mL.
------------------------------------------------------------------------
ANDA 62-873              Cephalexin for Oral      Do.
                          Suspension USP, 125 mg/
                          5mL.
------------------------------------------------------------------------
ANDA 62-961              Cefadyl (cephapirin)     Apothecon.
                          for Injection.
------------------------------------------------------------------------
ANDA 63-120              Tobramycin Sulfate       AstraZeneca LP.
                          Injection USP, 2 mL
                          vial, 40 mg/mL.
------------------------------------------------------------------------
ANDA 63-122              Tobramycin Sulfate       Do.
                          Injection USP, 40 mg/
                          mL.
------------------------------------------------------------------------
ANDA 64-131              Trimox (amoxicillin      Apothecon.
                          tablets USP), Tablets,
                          125 mg and 250 mg.
------------------------------------------------------------------------
ANDA 70-128              Propranolol HCl Tablets  ESI Lederle, c/o
                          USP, 80 mg.              Lederle Laboratories,
                                                   401 North Middletown
                                                   Rd., Pearl River, NY
                                                   10965-1299.
------------------------------------------------------------------------
ANDA 70-318              Haloperidol Oral         Alpharma, U.S.
                          Solution USP             Pharmaceuticals
                          (Concentrate), 2 mg/     Division, 200 Elmora
                          mL.                      Ave., Elizabeth, NJ
                                                   07207.
------------------------------------------------------------------------
ANDA 70-757              Propranolol HCl Tablets  Purepac Pharmaceutical
                          USP, 80 mg.              Co., 200 Elmora Ave.,
                                                   Elizabeth, NJ 07207.
------------------------------------------------------------------------

[[Page 49486]]

 
ANDA 70-814              Propranolol HCl Tablets  Do.
                          USP, 10 mg.
------------------------------------------------------------------------
ANDA 70-815              Propranolol HCl Tablets  Do.
                          USP, 20 mg.
------------------------------------------------------------------------
ANDA 70-816              Propranolol HCl Tablets  Do.
                          USP, 40 mg.
------------------------------------------------------------------------
ANDA 70-817              Propranolol HCl Tablets  Do.
                          USP, 60 mg.
------------------------------------------------------------------------
ANDA 71-495              Propranolol HCl Tablets  ESI Lederle.
                          USP, 60 mg.
------------------------------------------------------------------------
ANDA 71-496              Propranolol HCl Tablets  Do.
                          USP, 90 mg.
------------------------------------------------------------------------
ANDA 71-673              Doxepin HCl Capsules     Do.
                          USP, 50 mg.
------------------------------------------------------------------------
ANDA 71-674              Doxepin HCl Capsules     Do.
                          USP, 75 mg.
------------------------------------------------------------------------
ANDA 71-675              Doxepin HCl Capsules     Do.
                          USP, 100 mg.
------------------------------------------------------------------------
ANDA 71-676              Doxepin HCl Capsules     Do.
                          USP, 150 mg.
------------------------------------------------------------------------
ANDA 71-685              Doxepin HCl Capsules     Do.
                          USP, 10 mg.
------------------------------------------------------------------------
ANDA 71-686              Doxepin HCl Capsules     Do.
                          USP, 25 mg.
------------------------------------------------------------------------
ANDA 72-026              Fentanyl Citrate and     AstraZeneca LP.
                          Droperidol Injection.
------------------------------------------------------------------------
ANDA 72-687              Foamicon (alumina and    Novartis Consumer
                          magnesium trisilicate    Health, Inc., 200
                          tablets USP), 80 mg      Kimball Dr.,
                          and 20 mg.               Parsippany, NJ 07054-
                                                   0622.
------------------------------------------------------------------------
ANDA 73-080              Loperamide HCl Capsules  Roxane Laboratoires,
                          USP, 2mg.                Inc., P.O. Box 16532,
                                                   Columbis, OH 43216.
------------------------------------------------------------------------
ANDA 73-403              Questran                 Bristol-Myers Squibb
                          (cholestyramine)         Co.
                          Tablets, 800 mg and
                          1,000 mg.
------------------------------------------------------------------------
ANDA 73-440              Desoximetasone Ointment  Altana, Inc., 60
                          USP, 0.25%.              Baylis Rd., Melville,
                                                   NY 11747.
------------------------------------------------------------------------
ANDA 73-494              Thiothixene HCl          Roxane Laboratories,
                          Intensol Oral Solution   Inc.
                          (Concentrate), 5 mg/
                          mL.
------------------------------------------------------------------------
ANDA 74-036              Piroxicam Capsules USP,  SCS Pharmaceuticals,
                          10 mg and 20 mg.         Box 5110, Chicago, IL
                                                   60680-9889.
------------------------------------------------------------------------
ANDA 74-734              Iopamidol Injection      Faulding
                          USP, 61% and 76%.        Pharmaceuticals, Mack-
                                                   Cali Centre 11, 650
                                                   From Rd., Paramus, NJ
                                                   07652.
------------------------------------------------------------------------
ANDA 75-100              Bromocriptine Mesylate   Lek, Pharmaceutical
                          Capsules USP, 5 mg.      and Chemical Co.
                                                   d.d., c/o Lek
                                                   Services, Inc., 115
                                                   North Third St.,
                                                   Suite 301,
                                                   Wilmington, NC 28401.
------------------------------------------------------------------------
ANDA 75-223              Labetalol HCl Tablets    Apothecon.
                          USP, 100 mg, 200 mg,
                          and 300 mg.
------------------------------------------------------------------------
ANDA 80-081              Sulfadiazine Tablets     Impax Laboratories,
                          USP, 500 mg.             Inc., 30831 Huntwood
                                                   Ave., Hayward, CA
                                                   94544.
------------------------------------------------------------------------
ANDA 80-254              Testosterone Propionate  Eli Lilly and Co.
                          Injection USP, 50 mg/
                          mL.
------------------------------------------------------------------------
ANDA 80-686              Folic Acid Tablets USP,  Impax Laboratories,
                          1 mg.                    Inc.
------------------------------------------------------------------------
ANDA 80-781              Hydrocortisone Tablets   Do.
                          USP, 20 mg.
------------------------------------------------------------------------
ANDA 80-785              Tripelennamine HCl       Do.
                          Tablets USP, 50 mg.
------------------------------------------------------------------------
ANDA 80-853              Betalin-S (thiamine HCl  Eli Lilly and Co.
                          injection USP), 100 mg/
                          mL.
------------------------------------------------------------------------
ANDA 83-209              Estratab Tablets         Solvay
                          (esterified estrogens    Pharmaceuticals, Inc.
                          tablets USP) 0.625 mg.
------------------------------------------------------------------------
ANDA 83-488              Estrogenic Substance     Wyeth Pharmaceuticals.
                          (sterile estrone
                          suspension USP) for
                          Injection.
------------------------------------------------------------------------

[[Page 49487]]

 
ANDA 83-607              Hydrochlorothiazide      Impax Laboratories,
                          Tablets USP.             Inc.
------------------------------------------------------------------------
ANDA 83-720              Probenecid and           Do.
                          Colchicine Tablets
                          USP, 500 mg/0.5 mg.
------------------------------------------------------------------------
ANDA 83-789              Furacin (nitrofurazone)  Shire Pharmaceutical
                          Topical Cream.           Development, Inc.
------------------------------------------------------------------------
ANDA 83-967              Trichlormethiazide       Impax Laboratories,
                          Tablets USP, 4 mg.       Inc.
------------------------------------------------------------------------
ANDA 84-029              Hydrochlorothiazide      Do.
                          Tablets USP, 25 mg.
------------------------------------------------------------------------
ANDA 84-444              Phenaphen with Codeine   A.H. Robins Co.
                          (acetaminophen and
                          codeine phosphate
                          capsules USP), No. 2
                          Capsules, 325 mg/15
                          mg.
------------------------------------------------------------------------
ANDA 84-541              Propantheline Bromide    Impax Laboratories,
                          Tablets USP, 15 mg.      Inc.
------------------------------------------------------------------------
ANDA 85-057              Tylenol With Codeine     Ortho-McNeil
                          (acetaminophen and       Pharmaceuticals,
                          codeine phosphate oral   Inc., c/o Johnson &
                          solution USP) Elixir,    Johnson
                          120 mg/12 mg.            Pharmaceutical
                                                   Research and
                                                   Development, L.L.C.,
                                                   920 Route 202 South,
                                                   P.O. Box 300,
                                                   Raritan, NJ 08869-
                                                   0602.
------------------------------------------------------------------------
ANDA 85-856              Phenaphen-650 With       A.H. Robbins Co.
                          Codeine (acetaminophen
                          and codeine phosphate
                          tablets USP) Tablets,
                          650 mg/30 mg.
------------------------------------------------------------------------
ANDA 86-405              Sorbitrate (isosorbide   AstraZeneca
                          dinitrate tablets        Pharmaceuticals LP.
                          USP), 20 mg.
------------------------------------------------------------------------
ANDA 86-530              Seconal (secobarbital    Eli Lilly and Co.
                          sodium) Suppositories.
------------------------------------------------------------------------
ANDA 86-683              Acetaminophen and        Purpac Pharmaceutical
                          Codeine Phosphate        Co.
                          Tablets USP, 300 mg/60
                          mg.
------------------------------------------------------------------------
ANDA 86-715              Estratab Tablets         Solvay
                          (esterified estrogens    Pharmaceuticals.
                          tablets USP), 0.3 mg.
------------------------------------------------------------------------
ANDA 87-158              Fluonid (fluocinolone    Allergan, 2525 Dupont
                          acetonide) Solution,     Dr., P.O. Box 19534,
                          0.01%.                   Irvine, GA 92623-
                                                   9534.
------------------------------------------------------------------------
ANDA 87-847              Atropine and Demerol     Abbott Laboratories.
                          (atropine sulfate and
                          meperidine HCl)
                          Injection, 0.4 mg/75
                          mg/mL.
------------------------------------------------------------------------
ANDA 87-848              Atropine and Demerol     Do.
                          (atropine sulfate and
                          meperidine HCl)
                          Injection, 0.4 mg/100
                          mg/mL.
------------------------------------------------------------------------
ANDA 87-853              Atropine and Demerol     Do.
                          (atropine sulfate and
                          meperidine HCl)
                          Injection, 0.4 mg/50
                          mg/mL.
------------------------------------------------------------------------
ANDA 87-864              Triple Sulfa Vaginal     Alpharma.
                          Cream (sulfathiazole,
                          sulfacetamide, and
                          sufabenzamide).
------------------------------------------------------------------------
ANDA 88-125              Sorbitrate (isosorbide   AstraZeneca
                          dinitrate tablets        Pharmaceuticals, LP.
                          USP), 40 mg.
------------------------------------------------------------------------
ANDA 88-343              Bromanyl                 Alpharma.
                          (bromodiphenhydramine
                          HCl and codeine
                          phosphate) Cough
                          Syrup, 12.5 mg/5 mL
                          and 10 mg/5 mL).
------------------------------------------------------------------------
ANDA 89-561              Chlorpropamide Tablets   Lederle Laboratories.
                          USP, 100 mg.
------------------------------------------------------------------------
ANDA 89-562              Chlorpropamide Tablets   Do.
                          USP, 250 mg.
------------------------------------------------------------------------


[[Page 49488]]

    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 17, 2003

    Dated: July 18, 2003.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 03-20949 Filed 8-15-03; 8:45 am]
BILLING CODE 4160-01-S