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


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0058]


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

AGENCY:  Food and Drug Administration, HHS.

[[Page 10652]]


ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is withdrawing 
approval of 76 new drug applications (NDAs) and 60 abbreviated new drug 
applications (ANDAs) from multiple applicants. The holders of the 
applications notified the agency in writing that the drug products were 
no longer marketed and requested that the approval of the applications 
be withdrawn.

EFFECTIVE DATE:  April 4, 2005.

FOR FURTHER INFORMATION CONTACT:  Florine P. Purdie, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in 
the table in this document have informed FDA that these drug products 
are no longer marketed and have requested that FDA withdraw approval of 
the applications. The applicants have also, by their requests, waived 
their opportunity for a hearing.

------------------------------------------------------------------------
   Application No.              Drug                    Applicant
------------------------------------------------------------------------
NDA 6-095             Tubocurarine Chloride     Hospira, Inc., 275 North
                       Injection                 Field Dr., Bldg. 2-J45-
                                                 2, Lake Forest, IL
                                                 60045-5046
------------------------------------------------------------------------
NDA 6-412             Decapryn (doxylamine      Aventis Pharmaceuticals,
                       succinate) Tablets and    Inc., 200 Crossing
                       Syrup                     Blvd., Bridgewater, NJ
                                                 08807-0890
------------------------------------------------------------------------
NDA 6-460             Protamine Sulfate         Eli Lilly and Co., Lilly
                       Injection USP             Corporate Center,
                                                 Indianapolis, IN 46285
------------------------------------------------------------------------
NDA 8-032             Telepaque (iopanoic       Amersham Health, 101
                       acid) Tablets             Carnegie Center,
                                                 Princeton, NJ 08540
------------------------------------------------------------------------
NDA 10-288            Betadine (10% povidone    The Purdue Frederick
                       iodine) Solution and      Co., One Stamford
                       Isodine (10% povidone     Forum, Stamford, CT
                       iodine) Solution          06901-3431
------------------------------------------------------------------------
NDA 11-097            Dimetane                  Wyeth Consumer
                       (brompheniramine          Healthcare, Five
                       maleate) Elixir           Giralda Farms, Madison,
                                                 NJ 07940
------------------------------------------------------------------------
NDA 11-270            Furoxone (furazolidone)   Shire Laboratories,
                       Tablets                   Inc., c/o Shire
                                                 Pharmaceutical
                                                 Development, Inc., 1801
                                                 Research Blvd., suite
                                                 600, Rockville, MD
                                                 20850
------------------------------------------------------------------------
NDA 11-323            Furoxone (furazolidone)   Do.
                       Oral Suspension
------------------------------------------------------------------------
NDA 11-325            Vesprin (triflupromazine  Apothecon, c/o Bristol-
                       hydrochloride (HCl))      Myers Squibb Co., P.O.
                       Injection, 10             Box 4500, Princeton, NJ
                       milligrams (mg)/          08543-4500
                       milliliter (mL) and 20
                       mg/mL
------------------------------------------------------------------------
NDA 11-367            Enzactin (triacetin)      Wyeth Consumer
                       Spray                     Healthcare
------------------------------------------------------------------------
NDA 12-265            Naqua                     Schering Corp., 2000
                       (trichlormethiazide)      Galloping Hill Rd.,
                       Tablets and Naquival      Kenilworth, NJ 07033
                       (trichlormethiazide and
                       reserpine) Tablets
------------------------------------------------------------------------
NDA 12-320            Rauzide (rauwolfia        Apothecon, c/o Bristol-
                       serpentine with           Myers Squibb Co.
                       bendroflumethiazide)
                       Tablets and Rautrax-N
                       Tablets
------------------------------------------------------------------------
NDA 12-728            Ortho-Novum 1/50-21       Ortho-McNeil
                       (norethindrone and        Pharmaceuticals, Inc.,
                       mestranol) Tablets        c/o Johnson & Johnson
                                                 Research and
                                                 Development, L.L.C.,
                                                 920 Route 202 South,
                                                 Box 300, Raritan, NJ
                                                 08869-0602
------------------------------------------------------------------------
NDA 16-993            Adsorbotear Ophthalmic    Alcon Laboratories,
                       Solution                  Inc., 6201 South
                                                 Freeway, Fort Worth, TX
                                                 76134
------------------------------------------------------------------------
NDA 17-471            Sodium Pertechnetate Tc-  Amersham Health
                       99m (technetium Tc-99m
                       sodium pertechnetate)
                       Solution
------------------------------------------------------------------------
NDA 17-488            Modicon 21                Ortho-McNeil
                       (norethindrone and        Pharmaceuticals, Inc.,
                       ethinyl estradiol)        c/o Johnson & Johnson
                       Tablets                   Research and
                                                 Development, L.L.C.
------------------------------------------------------------------------
NDA 17-489            Ortho-Novum 1/35-21       Do.
                       (norethindrone and
                       ethinyl estradiol)
                       Tablets and Neocon
                       Tablets (norethindrone
                       and ethinyl estradiol)
------------------------------------------------------------------------
NDA 17-561            Celstone (betamethasone   Schering Corp.
                       sodium phosphate USP)
                       Injection
------------------------------------------------------------------------
NDA 17-601            Optimine (azatadine       Do.
                       maleate USP) Tablets
------------------------------------------------------------------------

[[Page 10653]]

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

[[Page 10654]]

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

[[Page 10655]]

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

[[Page 10656]]

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


[[Page 10657]]

    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the 
Director, Center for Drug Evaluation and Research, by the Commissioner, 
approval of the applications listed in the table in this document, and 
all amendments and supplements thereto, is hereby withdrawn, effective 
April 4, 2005.

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