[Federal Register: May 5, 2004 (Volume 69, Number 87)]
[Notices]               
[Page 25124-25130]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my04-86]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0159]

 
Schering Corp. et al.; Withdrawal of Approval of 92 New Drug 
Applications and 49 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 92 new drug applications (NDAs) and 49 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requested that the approval of the applications be withdrawn.

DATES: June 4, 2004

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.

[[Page 25125]]



------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 5-292                Estinyl (ethinyl         Schering Corp., 2000
                          estradiol) Tablets       Galloping Hill Rd.,
                                                   Kenilworth, NJ 07033
------------------------------------------------------------------------
NDA 5-795                Furacin (nitrofurazone)  Shire Pharmaceutical
                                                   Development, Inc.,
                                                   1801 Research Blvd.,
                                                   suite 600, Rockville,
                                                   MD 20850
------------------------------------------------------------------------
NDA 6-110                Dienestrol (dienestrol)  Ortho-McNeil
                          Cream                    Pharmaceutical, Inc.,
                                                   c/o Johnson & Johnson
                                                   Research &
                                                   Development, L.L.C.,
                                                   920 Highway 202, P.O.
                                                   Box 300, Raritan, NJ
                                                   08869[numsign]-0602
------------------------------------------------------------------------
NDA 6-800                Paradione                Abbott Laboratories, D-
                          (paramethadione)         491/AP30-1E, 200
                                                   Abbott Park Rd.,
                                                   Abbott Park, IL 60064-
                                                   6157
------------------------------------------------------------------------
NDA 7-110                Cortone Acetate          Merck & Co., Inc.,
                          (cortisone acetate       Sumneytown Pike,
                          injectable suspension   BLA-20, P.O. Box 4,
                          USP) Injectable          West Point, PA 19486
                          Suspension
------------------------------------------------------------------------
NDA 7-707                Phenurone (phenacemide)  Abbott Laboratories
                          Tablets
------------------------------------------------------------------------
NDA 7-750                Cortone Acetate          Merck & Co., Inc.
                          (cortisone acetate
                          tablet USP) Tablets
------------------------------------------------------------------------
NDA 8-328                Spectrocin               Bristol-Myers Squibb
                                                   Co., P.O. Box 4000,
                                                   Princeton, NJ 08543-
                                                   4000
------------------------------------------------------------------------
NDA 8-604                Phenergan VC Syrup       Wyeth Pharmaceuticals,
                          (promethazine            P.O. Box 8299,
                          hydrochloride (HCl)      Philadelphia, PA
                          and phenylephrine HCl)   19101-8299
                          and Phenergan
                          Expectorant
                          (promethazine HCl,
                          ipecac, and potassium
                          guaiacolsulfonate)
------------------------------------------------------------------------
NDA 8-857                Phenergan Injection      Do.
                          (promethazine HCl)
------------------------------------------------------------------------
NDA 9-298                Amm-I-Dent (sodium       Block Drug Co., Inc.,
                          lauroyl sarcosinate/     257 Cornelison Ave.,
                          urea/ammonium            Jersey City, NJ 07302
                          phosphate) Toothpaste
                          and Tooth Powder
------------------------------------------------------------------------
NDA 10-039               Avlosulfon (dapsone)     Wyeth Pharmaceuticals
                          Tablets
------------------------------------------------------------------------
NDA 10-727               Peri-Colace Capsules     Shire Pharmaceutical
                          (30 milligrams (mg)      Development, Inc.
                          casanthranol/100 mg
                          docusate sodium) and
                          Syrup (30 mg
                          casanthranol/60 mg
                          docusate sodium per 15
                          milliliters (mL))
------------------------------------------------------------------------
NDA 10-775               Trilafon (perphenazine)  Schering Corp.
                          Tablets
------------------------------------------------------------------------
NDA 10-858               Enzactin (triacetin)     Wyeth Consumer
                          Cream                    Healthcare, Five
                                                   Giralda Farms,
                                                   Madison, NJ 07940-
                                                   0871
------------------------------------------------------------------------
NDA 10-971               PMB (conjugated          Wyeth Pharmaceuticals
                          estrogens USP with
                          meprobamate) Tablets
------------------------------------------------------------------------
NDA 11-140               Enzactin (triacetin)     Wyeth Consumer
                          Powder                   Healthcare
------------------------------------------------------------------------
NDA 11-460               Lanesta (chlorindanol)   Sanofi-Synphelabo,
                          Vaginal Gel              Inc., 90 Park Ave.,
                                                   New York, NY 10016
------------------------------------------------------------------------
NDA 11-860               Humorsol (demecarium     Merck & Co., Inc.
                          bromide) Ophthalmic
                          Solution
------------------------------------------------------------------------
NDA 11-977               Decadron Ophthalmic      Do.
                          Ointment
                          (dexamethasone sodium
                          phosphate ophthalmic
                          ointment)
------------------------------------------------------------------------
NDA 12-052               Hydrocortone             Do.
                          (hydrocortisone sodium
                          phosphate injection
                          USP) Injection, 50 mg/
                          mL
------------------------------------------------------------------------
NDA 12-071               Decadron (dexamethasone  Do.
                          sodium phosphate
                          injection USP)
                          Injection, 4 mg/mL and
                          24 mg/mL
------------------------------------------------------------------------
NDA 12-095               Orinase (sterile         Pharmacia & Upjohn
                          tolbutamide sodium)      Co., 7000 Portage
                          Diagnostic Sterile       Rd., Kalamazoo, MI
                          Powder for Injection     49001-0199
------------------------------------------------------------------------

[[Page 25126]]


NDA 12-283               Hygroton                 Aventis
                          (chlorthalidone)         Pharmaceuticals,
                          Tablets, 25 mg, 50 mg,   Inc., Mail Stop BX2 -
                          and 100 mg               209G, 200 Crossing
                                                   Blvd., Bridgewater,
                                                   NJ 08807-0890
------------------------------------------------------------------------
NDA 12-359               Salutensin and           Shire Laboratories,
                          Salutensin-DEMI          Inc., c/o Shire
                          (hydroflumethiazide      Pharmaceutical
                          and reserpine) Tablets   Development, Inc.,
                                                   1801 Research Blvd.,
                                                   suite 600, Rockville,
                                                   MD 20850
------------------------------------------------------------------------
NDA 12-376               Decadron                 Merck & Co. Inc.
                          (dexamethasone)
                          Elixir, 0.5 mg/5 mL
------------------------------------------------------------------------
NDA 12-594               Metahydrin               Aventis
                          (trichlormethiazide)     Pharmaceuticals, Inc.
                          Tablets, 2 mg and 4 mg
------------------------------------------------------------------------
NDA 12-657               Celestone                Schering Corp.
                          (betamethasone tablets
                          USP) Tablets
------------------------------------------------------------------------
NDA 12-972               Metatensin               Aventis
                          (trichlormethiazide      Pharmaceuticals, Inc.
                          and reserpine)
                          Tablets, 2 mg/0.1 mg
                          and 4 mg/0.1 mg
------------------------------------------------------------------------
NDA 14-116               Johnson                  Johnson & Johnson
                          [numsign]Johnson First   Consumer Products
                          Aid Spray (dequainium    Co., 199 Grandview
                          acetate and              Rd., Sillman, NJ
                          cetylpyridinium          08558
                          chloride)
------------------------------------------------------------------------
NDA 14-122               Protopam (pralidoxime    Wyeth Pharmaceuticals
                          chloride) Tablets
------------------------------------------------------------------------
NDA 14-127               Xylocaine (lidocaine)    AstraZeneca LP, 1800
                          5% Solution              Concord Pike, P.O.
                                                   Box 8355, Wilmington,
                                                   DE 19803-8355
------------------------------------------------------------------------
NDA 14-713               Etrafon (perphenazine    Schering Corp.
                          and amitriptyline HCl)
                          and Etrafon Forte
                          Tablets
------------------------------------------------------------------------
NDA 15-103               Regroton                 Aventis
                          (chlorthalidone, 50 mg   Pharmaceuticals, Inc.
                          and reserpine, 0.25
                          mg) and Demi-Regroton
                          (chlorthalidone, 25 mg
                          and reserpine, 0.125
                          mg) Tablets
------------------------------------------------------------------------
NDA 16-034               Vontrol (diphenidol      GlaxoSmithKline, One
                          HCl) Injection           Franklin Plaza, P.O.
                                                   Box 7929,
                                                   Philadelphia, PA
                                                   19101-7929
------------------------------------------------------------------------
NDA 16-035               Vontrol (diphenidol      Do.
                          pamoate) Suspension
------------------------------------------------------------------------
NDA 16-036               Vontrol (diphenidol)     Do.
                          Suppositories
------------------------------------------------------------------------
NDA 16-087               Valium (diazepam)        Roche Laboratories,
                          Injection                Inc., 340 Kingsland
                                                   St., Nutley, NJ 07110-
                                                   1199
------------------------------------------------------------------------
NDA 16-110               Prolixin (fluphenazine   Apothecon, c/o Bristol-
                          enanthate) Injection,    Myers Co., P.O. Box
                          25 mg/mL                 4500, Princeton, NJ
                                                   08543-4500
------------------------------------------------------------------------
NDA 16-618               Pondimin (fenfluramine   A.H. Robins Co., c/o
                          HCl) Tablets and         Wyeth
                          Ponderex (fenfluramine   Pharmaceuticals, P.O.
                          HCl) Capsules            Box 8299,
                                                   Philadelphia, PA
                                                   19101-8299
------------------------------------------------------------------------
NDA 16-647               Quinaglute (quinidine    Berlex Laboratories,
                          gluconate) Dura-Tabs     Inc., 340
                                                   Changebridge Rd.,
                                                   P.O. Box 1000,
                                                   Montville, NJ 07045-
                                                   1000
------------------------------------------------------------------------
NDA 16-786               Ovral 28 (norgestrel/    Wyeth Pharmaceuticals
                          ethinyl estradiol) and
                          Ferrous Fumarate
                          Tablets
------------------------------------------------------------------------
NDA 16-803               Bronkaid (epinephrine    Bayer Consumer Care
                          inhalation aerosol)      Division, 36 Columbia
                          Mist                     Rd., P.O. Box 1910,
                                                   Morristown, NJ 07962-
                                                   1910
------------------------------------------------------------------------
NDA 16-849               Selsun Blue Shampoo      Ross Laboratories, 625
                                                   Cleveland Ave.,
                                                   Columbus, OH 43215-
                                                   1754
------------------------------------------------------------------------
NDA 16-883               Antiminth (pyrantel      Pfizer Consumer
                          pamoate) Oral            Healthcare, 201 Tabor
                          Suspension               Rd., Morris Plains,
                                                   NJ 07950
------------------------------------------------------------------------
NDA 16-912               Larodopa (levadopa)      Hoffman-La Roche,
                          Tablets and Capsules     Inc., 340 Kingsland
                                                   St., Nutley, NJ 07110-
                                                   1199
------------------------------------------------------------------------

[[Page 25127]]


NDA 16-985               Gleem (sodium fluoride)  Proctor & Gamble
                          Dentrifice               Pharmaceuticals,
                                                   Inc., Oral Care
                                                   Products Division,
                                                   8700 Mason-Montgomery
                                                   Rd., Mason, OH 45040
------------------------------------------------------------------------
NDA 17-020               Panwarfin (warfarin      Abbott Laboratories
                          sodium tablets USP)
                          Tablets, 2 mg, 2.5 mg,
                          5 mg, 7.5 mg, 10 mg,
                          and 25 mg
------------------------------------------------------------------------
NDA 17-389               Dial 2 (pyrithione       Armour-Dial, Inc.,
                          zinc) Dandruff Shampoo   15101 N. Scottsdale
                                                   Rd., Scottsdale, AZ
                                                   85260
------------------------------------------------------------------------
NDA 17-535               Lorelco (probucol)       Aventis
                          Tablets                  Pharmaceuticals, Inc.
------------------------------------------------------------------------
NDA 17-536               Diprosone                Schering Corp.
                          (betamethasone
                          dipropionate) Cream,
                          0.05%
------------------------------------------------------------------------
NDA 17-684               Pyrolite (technetium Tc- CIS-US, Inc., 10 De
                          99m pyro- and trimeta-   Angelo Dr., Bedford,
                          phosphates kit)          MA 01730
------------------------------------------------------------------------
NDA 17-710               Nalfon (fenoprofen       Dista Products Ltd., c/
                          calcium) Tablets         o Eli Lilly and Co.,
                                                   Lilly Corporate
                                                   Center, Indianapolis,
                                                   IN 46285
------------------------------------------------------------------------
NDA 17-736               Paxipam (halazepam)      Schering Corp.
                          Tablets, 20 mg and 40
                          mg
------------------------------------------------------------------------
NDA 17-853               Proventil (albuterol     Do.
                          sulfate) Tablets, 2 mg
                          and 4 mg
------------------------------------------------------------------------
NDA 17-895               Janimine (imipramine     Abbott Laboratories
                          HCl) Tablets
------------------------------------------------------------------------
NDA 17-952               Trimpex (trimethoprim)   Hoffman-La Roche, Inc.
                          Tablets
------------------------------------------------------------------------
NDA 18-306               NasalCrom (cromolyn      Pharmacia Consumer
                          sodium) Nasal Solution   Healthcare, 100 Route
                                                   206 North, Peapack,
                                                   NJ 07977
------------------------------------------------------------------------
NDA 18-521               Vancenase                Schering Corp.
                          (beclomethasone
                          dipropionate) Nasal
                          Inhaler
------------------------------------------------------------------------
NDA 18-584               Beconase                 GlaxoSmithKline, P.O.
                          (beclomethasone          Box 13398, Five Moore
                          dipropionate)            Dr., Research
                          Inhalation Aerosol       Triangle Park, NC
                                                   27709
------------------------------------------------------------------------
NDA 18-587               Wytensin (guanabenz      Wyeth Pharmaceuticals
                          acetate) Tablets, 4
                          mg, 8 mg, and 16 mg
------------------------------------------------------------------------
NDA 18-592               Monistat 5 (miconazole   Personal Products Co.,
                          nitrate) Tampons, 100    199 Grandview Rd.,
                          mg                       Skillman, NJ 08558
------------------------------------------------------------------------
NDA 19-059               Inderide LA              Ayerst
                          (propranolol HCl and     Pharmaceuticals, c/o
                          hydrochlorothiazide)     Wyeth Ayerst
                          Capsules, 80 mg/50 mg,   Laboratories, P.O.
                          120 mg/50 mg, and 160    Box 8299,
                          mg/50 mg                 Philadelphia, PA
                                                   19101-8299
------------------------------------------------------------------------
NDA 19-279               Dimetane DX              A.H. Robins Co., c/o
                          (brompheniramine         Wyeth Pharmaceuticals
                          maleate/
                          pseudoephedrine HCl/
                          dextromethorphan HBr)
                          Cough Syrup
------------------------------------------------------------------------
NDA 19-428               Pseudoephedrine HCl and  Central
                          Chlorpheniramine         Pharmaceuticals, c/o
                          Maleate Extended-        Schwarz Pharma, Inc.,
                          Release Capsules         P.O. Box 2038,
                                                   Milwaukee, WI 53201
------------------------------------------------------------------------
NDA 19-757               Chibroxin (norfloxacin)  Merck &Co., Inc.
                          Sterile Ophthalmic
                          Solution, 0.3%
------------------------------------------------------------------------
NDA 19-858               Cipro (ciprofloxacin)    Bayer Corp.
                          in Sodium Chloride
------------------------------------------------------------------------
NDA 20-055               Glyburide (micronized)   Aventis
                          Tablets                  Pharmaceuticals, Inc.
------------------------------------------------------------------------
NDA 20-058               Thioplex (thiotepa) For  Immunex Corp., 51
                          Injection)               University St.,
                                                   Seattle, WA 98101-
                                                   2936
------------------------------------------------------------------------
NDA 20-135               Motrin (ibuprofen)       McNeil Consumer &
                          Chewable Tablets         Specialty
                                                   Pharmaceuticals, 7050
                                                   Camp Hill Rd., Fort
                                                   Washington, PA 19034-
                                                   2299
------------------------------------------------------------------------

[[Page 25128]]


NDA 20-233               Rhinocort (budesomide)   AstraZeneca LP
                          Nasal Inhaler
------------------------------------------------------------------------
NDA 20-240               Renormax (spirapril      Schering Corp.
                          HCl) Tablets, 3 mg, 6
                          mg, 12 mg, and 24 mg
------------------------------------------------------------------------
NDA 20-418               Motrin (ibuprofen)       McNeil Consumer &
                          Caplets                  Specialty
                                                   Pharmaceuticals
------------------------------------------------------------------------
NDA 20-469               Vancenase AQ             Schering Corp.
                          (beclomethasone
                          dipropionate
                          monohydrate) Nasal
                          Spray
------------------------------------------------------------------------
NDA 20-476               Motrin (ibuprofen) Oral  McNeil Consumer
                          Drops                    &Specialty
                                                   Pharmaceuticals
------------------------------------------------------------------------
NDA 20-874               Lunelle (estradiol       Pharmacia Corp., c/o
                          cypionate and            Pfizer
                          medroxyprogesterone      Pharmaceuticals
                          acetate) Injection       Group, 235 E. 42d
                                                   St., New York, NY
                                                   10017-5755
------------------------------------------------------------------------
NDA 20-951               Tagamet HB (cimetidine)  GlaxoSmithKline
                          Suspension               Consumer Healthcare
                                                   LP, 1500 Littleton
                                                   Rd., Parsippany, NJ
                                                   07054-3884
------------------------------------------------------------------------
NDA 50-012               Garamycin (gentamicin    Schering Corp.
                          sulfate injection USP)
                          Injectable
------------------------------------------------------------------------
NDA 50-051               Grisactin                Wyeth Pharmaceuticals
                          (griseofulvin,
                          microcrystalline)
                          Capsules
------------------------------------------------------------------------
NDA 50-092               Pathocil (dicloxacillin  Do.
                          sodium) for Suspension
------------------------------------------------------------------------
NDA 50-094               Erythrocin               Abbott Laboratories
                          (erythromycin)
                          Suppositories
------------------------------------------------------------------------
NDA 50-111               Unipen (nafcillin        Wyeth Pharmaceuticals
                          sodium) Capsules
------------------------------------------------------------------------
NDA 50-262               Declomycin               Lederle Laboratories,
                          (demeclocycline HCl)     c/o Wyeth
                          Capsules                 Pharmaceuticals, P.O.
                                                   Box 8299,
                                                   Philadelphia, PA
                                                   19101-8299
------------------------------------------------------------------------
NDA 50-273               Achromycin               Do.
                          (tetracycline HCl)
                          Intravenous Injection
------------------------------------------------------------------------
NDA 50-276               Achromycin               Do.
                          (tetracyclilne HCl and
                          procaine HCl) Sterile
                          Intramuscular
                          Injection
------------------------------------------------------------------------
NDA 50-296               Erythrocin Suspension    Abbott Laboratories
------------------------------------------------------------------------
NDA 50-324               Neodecadron (neomycin    Merck Research
                          sulfate and              Laboratories,
                          dexamethasone sodium     Sumneytown Pike, P.O.
                          phosphate) Ophthalmic    Box 4, BLA-20, West
                          Ointment                 Point, PA 19486-0004
------------------------------------------------------------------------
NDA 50-341               Fungizone (amphotericin  Bristol-Myers Squibb
                          B) Oral Suspension       Co.
------------------------------------------------------------------------
NDA 50-425               Garamycin (gentamicin    Schering Corp.
                          sulfate) Ophthalmic
                          Ointment
------------------------------------------------------------------------
NDA 50-439               Erythrocin               Abbott Laboratories
                          (erythromycin
                          stearate)
------------------------------------------------------------------------
NDA 50-482               Keflin (cephalothin      Lilly Research
                          sodium) for Injection    Laboratories, Lilly
                                                   Corporate Center,
                                                   Indianapolis, IN
                                                   46285
------------------------------------------------------------------------
NDA 50-744               Periostat (doxycycline   CollaGenex
                          hyclate USP) Capsules,   Pharmaceuticals,
                          20 mg                    Inc., 301 South State
                                                   St., Newtown, PA
                                                   18940
------------------------------------------------------------------------
ANDA 60-006              Pen-Vee K (penicillin V  Wyeth Pharmaceuticals
                          potassium) Tablets,
                          125 mg, 250 mg, and
                          500 mg (base)
------------------------------------------------------------------------
ANDA 60-611              Neomycin Sulfate and     Pharmacia & Upjohn
                          Methylprednisolone       Co., 7000 Portage
                          Acetate Topical Cream    Rd., Kalamazoo, MI
                                                   49001
------------------------------------------------------------------------
ANDA 60-624              Omnipen (ampicillin)     Wyeth Pharmaceuticals
                          Capsules, 250 mg and
                          500 mg
------------------------------------------------------------------------
ANDA 62-178              Grisactin Ultra          Do.
                          (griseofulvin,
                          ultramicro
                          crystalline) Tablets,
                          125 mg and 250 mg
------------------------------------------------------------------------

[[Page 25129]]


ANDA 62-438              Grisactin Ultra          Do.
                          (griseofulvin,
                          ultramicro
                          crystalline) Tablets,
                          165 mg and 330 mg
------------------------------------------------------------------------
ANDA 62-549              Keflin (cephalothin      Lilly Research
                          sodium for injection     Laboratories
                          USP), 1 g and 2 g
------------------------------------------------------------------------
ANDA 62-690              Ticar (ticarcillin       GlaxoSmithKline
                          disodium) Injection, 3
                          g
------------------------------------------------------------------------
ANDA 62-905              Clindamycin Phosphate    Loch Pharmaceuticals,
                          Injection USP, 150 mg/   c/o Bedford
                          mL                       Laboratories, 300
                                                   Northfield Rd.,
                                                   Bedford, OH 44146
------------------------------------------------------------------------
ANDA 63-087              Lincomycin HCl USP       Abbott Laboratories
------------------------------------------------------------------------
ANDA 63-321              Vancoled (vancomycin     Lederle Laboratories,
                          HCl for oral solution    c/o Wyeth
                          USP)                     Pharmaceuticals
------------------------------------------------------------------------
ANDA 70-188              Naloxone HCl Injection   Wyeth Pharmaceuticals
                          USP, 0.02 mg/mL
------------------------------------------------------------------------
ANDA 70-189              Naloxone HCl Injection   Do.
                          USP, 0.02 mg/mL
------------------------------------------------------------------------
ANDA 70-190              Naloxone HCl Injection   Do.
                          USP, 0.4 mg/mL
------------------------------------------------------------------------
ANDA 70-191              Naloxone HCl Injection   Do.
                          USP, 0.4 mg/mL
------------------------------------------------------------------------
ANDA 70-480              Leucovorin Calcium for   Elkins Sinn, c/o Wyeth
                          Injection, 50 mg         Pharmaceuticals, P.O.
                                                   Box 8299,
                                                   Philadelphia, PA
                                                   19101-8299
------------------------------------------------------------------------
ANDA 70-917              Nalbuphine HCl           Abbott Laboratories
                          Injection, 20 mg/mL
------------------------------------------------------------------------
ANDA 72-639              Metoclopramide HCl       Clonmel Healthcare
                          Tablets USP, 10 mg       Ltd., c/o STADA
                                                   Pharmaceuticals Inc.,
                                                   U.S. Agent, 5 Cedar
                                                   Brook Dr., Cranbury,
                                                   NJ 08512
------------------------------------------------------------------------
ANDA 74-051              Diltiazem HCl Tablets    Apothecon, c/o Bristol-
                          USP, 30 mg, 60 mg, 90    Myers Squibb Co.,
                          mg, and 120 mg           P.O. Box 4500,
                                                   Princeton, NJ 08543-
                                                   4500
------------------------------------------------------------------------
ANDA 74-211              Naproxen Tablets USP,    Roxane Laboratories,
                          250 mg, 375 mg, and      Inc., P.O. Box 16532,
                          500 mg                   Columbus, OH 43216
------------------------------------------------------------------------
ANDA 74-257              Naproxen Sodium Tablets  Do.
                          USP
------------------------------------------------------------------------
ANDA 80-454              Meperidine HCl Tablets   Do.
                          USP, 50 mg
------------------------------------------------------------------------
ANDA 80-553              Thiamine HCl Injection   Do.
                          USP, 100 mg/mL
------------------------------------------------------------------------
ANDA 80-554              Cyanocobalamin           Do.
                          Injection USP
------------------------------------------------------------------------
ANDA 80-577              Diphenhydramine HCl      Do.
                          Injection USP, 50 mg/
                          mL
------------------------------------------------------------------------
ANDA 81-224              Leucovorin Calcium for   Elkins Sinn, c/o Wyeth
                          Injection, 100 mg        Pharmaceuticals
------------------------------------------------------------------------
ANDA 81-239              Cycrin                   Do.
                          (medroxyprogesterone
                          acetate) Tablets USP,
                          2.5 mg
------------------------------------------------------------------------
ANDA 81-240              Cycrin                   Do.
                          (medroxyprogesterone)
                          Tablets USP, 5 mg
------------------------------------------------------------------------
ANDA 83-159              Calcium Gluceptate       Abbott Laboratories
                          Injection
------------------------------------------------------------------------
ANDA 83-262              Secobarbital Sodium      Wyeth Pharmaceuticals
                          Injection USP, 50 mg/
                          mL
------------------------------------------------------------------------
ANDA 83-640              Quinidine Sulfate        Roxane Laboratories,
                          Tablets USP, 200 mg      Inc.
------------------------------------------------------------------------
ANDA 84-316              Dimenhydrinate           Wyeth Pharmaceuticals
                          Injection USP, 50 mg
------------------------------------------------------------------------
ANDA 84-386              Digoxin Injection USP,   Do.
                          500 micrograms/2 mL
------------------------------------------------------------------------
ANDA 84-445              Phenaphen with Codeine   A. H. Robins Co.
                          (acetaminophen and
                          codeine phosphate
                          capsules USP) No. 3
                          Capsules
------------------------------------------------------------------------

[[Page 25130]]


ANDA 84-446              Phenaphen with Codeine   Do.
                          (acetaminophen and
                          codeine phosphate
                          capsules USP) No. 4
                          Capsules
------------------------------------------------------------------------
ANDA 85-328              Theo-Dur (theophylline)  Schering Corp.
                          Extended-Release
                          Tablets, 100 mg and
                          300 mg
------------------------------------------------------------------------
ANDA 85-632              Quinidine Sulfate        Roxane Laboratories,
                          Tablets USP, 300 mg      Inc.
------------------------------------------------------------------------
ANDA 86-134              Nitro-Bid Ointment       Altana Inc., 60 Baylis
                          (nitroglycerin           Rd., Melville, NY
                          ointment USP, 2%)        11747
------------------------------------------------------------------------
ANDA 86-348              Prochlorperazine         Wyeth Pharmaceuticals
                          Edisylate Injection
                          USP, 5 mg (base)/mL
------------------------------------------------------------------------
ANDA 86-998              Theo-Dur (theophylline)  Schering Corp.
                          Extended-Release
                          Tablets, 200 mg
------------------------------------------------------------------------
ANDA 88-584              DHCplus (dihydrocodeine  Purdue Frederick Co.,
                          bitartrate,              One Stamford Forum,
                          acetaminophen, and       Stamford, CT 06901-
                          caffeine) Capsules,      3431
                          356.4 mg
------------------------------------------------------------------------
ANDA 89-116              Brompheril               Copley
                          (dexbrompheniramine      Pharmaceuticals,
                          maleate/                 Inc., c/o Teva
                          pseudoephedrine          Pharmaceuticals, 1090
                          sulfate) Extended-       Horsham Rd., North
                          Release Tablets, 6 mg/   Wales, PA 19454
                          120 mg
------------------------------------------------------------------------
ANDA 89-131              Theo-Dur (theophylline)  Schering Corp.
                          Extended-Release
                          Tablets, 450 mg
------------------------------------------------------------------------
ANDA 89-386              Cycrin                   Wyeth Pharmaceuticals
                          (medroxyprogesterone
                          acetate) Tablets, 10
                          mg
------------------------------------------------------------------------
ANDA 89-573              Methylprednisolone       Abbott Laboratories
                          Sodium Succinate for
                          Injection USP, 40 mg
------------------------------------------------------------------------
ANDA 89-574              Methylprednisolone       Do.
                          Sodium Succinate for
                          Injection USP, 125 mg
------------------------------------------------------------------------
ANDA 89-575              Methylprednisolone       Do.
                          Sodium Succinate for
                          Injection USP, 500 mg
------------------------------------------------------------------------
ANDA 89-576              Methylprednisolone       Do.
                          Sodium Succinate for
                          Injection USP, 1000 mg
------------------------------------------------------------------------
ANDA 89-822              Uni-Dur (theophylline)   Schering Corp.
                          Extended-Release
                          Tablets, 400 mg
------------------------------------------------------------------------
ANDA 89-823              Uni-Dur (theophylline)   Do.
                          Extended-Release
                          Tablets, 600 mg
------------------------------------------------------------------------

    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the 
Director, Center for Drug Evaluation and Research by the Commissioner, 
approval of the applications listed in the table in this document, and 
all amendments and supplements thereto, is hereby withdrawn, effective 
June 4, 2004.

    Dated: March 22, 2004.
Steven K. Galson,
Acting Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 04-10194 Filed 5-4-04; 8:45 am]

BILLING CODE 4160-01-S