[Federal Register Volume 65, Number 191 (Monday, October 2, 2000)]
[Notices]
[Pages 58775-58777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24844]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1516]


Apothecon, Inc., et al.; Withdrawal of Approval of 76 Abbreviated 
New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 76 abbreviated new drug applications (ANDA's). The holders of the 
applications notified the agency in writing that the drug products were 
no longer marketed and requested that the approval of the applications 
be withdrawn.

EFFECTIVE DATE: October 10, 2000.

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

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

 
------------------------------------------------------------------------
 ANDA No.              Drug                        Applicant
------------------------------------------------------------------------
60-100      Crysticillin (Penicillin   Apothecon, Inc., P.O. Box 4500,
             G Procaine Suspension      Princeton, NJ 08543.
             USP).
60-618      Grifulvin V (Griseofluvin  Johnson & Johnson Consumer Co,
             Microsize) Tablets, 125    Inc., 199 Grandview Rd.,
             milligrams (mg), 250 mg,   Skillman, NJ 08858.
             and 500 mg.
61-220      Opthochlor                 Parkedale Pharmaceuticals, Inc.,
             (Chloramphenicol           501 Fifth St., Bristol, TN
             Ophthalmic Solution USP)   37620.
             5 mg/milliliter (mL).
61-334      Bactocill (Oxacillin       SmithKline Beecham
             Sodium for Injection).     Pharmaceuticals, One Franklin
                                        Plaza, P.O. Box 7929,
                                        Philadelphia, PA 19101.
61-449      Staphcillin (Methicillin   Apothecon, Inc.
             Sodium).
61-452      Cloxacillin Sodium         Do.
             Capsules USP, 250 mg and
             500 mg.
61-739      Garamycin Pediatric        Schering Corp., 2000 Galloping
             Injection (Gentamicin      Hill Rd., Kenilworth, NJ 07033.
             Sulfate Injection USP).
62-328      Erythromycin Topical       Alpharma, 333 Cassell Dr., suite
             Solution USP, 1.5%.        3500, Baltimore, MD 21224.
62-727      Totacillin-N (Ampicillin   Smithkline Beecham
             Sodium) for Injection.     Pharmaceuticals.
62-755      Nallpen (Nafcillin Sodium  Do.
             Powder for Injection
             USP).
70-356      Diazepam Tablets USP, 2    Roxane Laboratories, Inc., P.O.
             mg.                        Box 16532, Columbus, OH 43216.
70-357      Diazepam Tablets USP, 5    Do.
             mg.
70-358      Diazepam Tablets USP, 10   Do.
             mg.
71-010      Acetominophen              Do.
             Suppositories, 120 mg.
71-011      Acetominophen              Do.
             Suppositories, 650 mg.
71-018      Metaproterenol Sulfate     AstraZeneca, L.P.
             Inhalation Solution USP,
             0.6%.
71-275      Metaproterenol Sulfate     Do.
             Inhalation Solution USP,
             0.4%.
72-018      Droperidol Injection USP,  Do.
             2.5 mg/mL.
72-019      Droperidol Injection USP,  Do.
             2.5 mg/mL.
72-021      Droperidol Injection USP,  Do.
             2.5 mg/mL.
72-648      Timolol Maleate Tablets    Novopharm Limited, c/o Novopharm
             USP, 5 mg.                 NC, Inc., 4700 Novopharm Blvd.,
                                        Wilson, NC 27893.
72-649      Timolol Maleate Tablets    Do.
             USP, 10 mg.
72-650      Timolol Maleate Tablets    Do.
             USP, 20 mg.

[[Page 58776]]

 
73-187      Loperamide Hydrochloride   Alpharma.
             Oral Solution, 1 mg/5
             mL.
73-340      Prometa Inhalation         Muro Pharmaceutical, Inc., 890
             Solution (Metaproternol    East St., Tewksbury, MA 01876.
             Sulfate Inhalation
             Solution USP), 5%.
74-361      Cimetidine Tablets USP,    Roxane Laboratories, Inc.
             300 mg, 400 mg, and 800
             mg.
74-371      Cimetidine Tablets USP,    Do.
             800 mg.
74-790      Ketorolac Tromethamine     Do.
             Tablets USP.
74-832      Captopril and              Danbury Pharmacal, Inc., 131 West
             Hydrochlorothiazide        St., Danbury, CT 06810.
             Tablets USP, 50 mg/25
             mg.
80-001      Calcium Gluceptate         Abbott Laboratories.
             Injection USP.
80-327      Prednisolone Tablets USP,  Roxane Laboratories, Inc.
             5 mg.
80-474      Hytone (Hydrocortisone)    Dermik Laboratories, Inc., 500
             Ointment 0.25%, 0.5%,      Arcola Rd., P.O. Box 1200,
             1%, and 2.5%.              Collegeville, PA 19426-0107.
83-682      Phendimetrazine Tartrate   Zenith Goldline Pharmaceuticals,
             Tablets USP, 35 mg.        Inc., 140 Legerand Ave.,
                                        Northvale, NJ 07647.
84-655      Prednicen-M (Prednisone    Schwarz Pharma, Inc., P.O. Box
             Tablets USP), 5 mg.        2038, Milwaukee, WI 53201.
84-659      Acetominophen and Codeine  Roxane Laboratories, Inc.
             Phosphate Tablets USP,
             300 mg/15 mg.
84-667      Acetominophen and Codeine  Do.
             Phosphate Tablets USP,
             300 mg/60 mg.
84-811      Apresazide (Hydralazine    Novartis Pharmaceuticals Corp.
             Hydrochloride and
             Hydrochlorothiazide USP)
             Capsules, 100/50 mg.
 
84-990      Dexone (Dexamethasone      Solvay Pharmaceuticals, Inc., 901
             Tablets, USP), 1.5 mg.     Sawyer Rd., Marietta, GA 30062.
85-539      Flutex (Triamcinolone      Zenith Goldline Pharmaceuticals,
             Acetonide Cream USP),      Inc.
             0.1%, 0.5%, and 0.025%.
85-686      Curretab                   Solvay Pharmaceuticals, Inc.
             (Medroxyprogesterone
             Acetate Tablets, USP) 10
             mg.
85-733      Hydrocortisone Cream USP,  Zenith Goldline Pharmaceuticals,
             1%.                        Inc.
85-777      Selenium Sulfide Lotion    Do.
             USP, 2.5%.
85-873      Butabarbital Sodium        Alpharma.
             Elixir, 30 mg/5 mL.
85-944      Amitriptyline              Roxane Laboratories, Inc.
             Hydrochloride Tablets
             USP, 25 mg.
85-945      Amitriptyline              Do.
             Hydrochloride Tablets
             USP, 50 mg.
86-002      Amitriptyline              Do.
             Hydrochloride Tablets
             USP, 10 mg.
86-003      Amitriptyline              Do.
             Hydrochloride Tablets
             USP, 100 mg.
86-004      Amitriptyline              Do.
             Hydrochloride Tablets
             USP, 75 mg.
86-065      Procan SR (Procainamide    Parkedale Pharmaceuticals, Inc.
             Hydrochloride Extended-
             Release Tablets, USP),
             500 mg.
86-090      Amitriptyline              Roxane Laboratories, Inc.
             Hydrochloride Tablets
             USP, 150 mg.
87-025      Isoetharine Inhalation     Roxane Laboratories, Inc.
             Solution USP, 0.125%.
87-203      Flurandrenolide Lotion     Alpharma.
             USP.
87-328      Trifluoperazine            Zenith Goldline Pharmaceuticals,
             Hydrocholride Tablets      Inc.
             USP, 5 mg.
87-375      Flutex (Triamcinolone      Do.
             Acetonide Ointment USP).
87-376      Flutex (Triamcinolone      Do.
             Acetonide Ointment USP).
87-377      Flutex (Triamcinolone      Do.
             Acetonide Ointment USP).
87-396      Isoetharine Inhalation     Roxane Laboratories, Inc.
             Solution USP, 0.1%.
87-427      Nogenic HC                 Zenith Goldline Pharmaceuticals,
             (Hydrocortisone Cream      Inc.
             USP), 1%.
87-428      Triatex (Triamcinolone     Do.
             Acetonide Cream USP),
             0.5%.
87-429      Triatex (Triamcinolone     Do.
             Acetonide Cream USP),
             0.1%.
87-430      Triatex (Triamcinolone     Do.
             Acetonide Cream USP),
             0.025%.
87-510      Procan SR (Procainamide    Parkedale Pharmaceuticals, Inc.
             Hydrochloride Extended-
             Release Tablets, USP),
             750 mg.
87-611      Liquid Pred (Prednisone    Muro Pharmaceutical, Inc.
             Syrup USP), 5 mg/5 mL.
87-612      Trifluoperazine            Zenith Goldline Pharmaceuticals,
             Hydrochloride Tablets      Inc.
             USP, 1 mg.
87-613      Trifluoperazine            Do.
             Hydrochloride Tablets
             USP, 2 mg.
87-614      Trifluoperazine            Do.
             Hydrochloride Tablets
             USP, 10 mg.
87-742      Oxycodone Hydrochloride    Roxane Laboratories, Inc.
             2.25 mg, Oxycodone
             Terephthalate 0.19 mg,
             and Aspirin 325 mg
             Tablets.
88-275      Isoetharine Inhalation     Do.
             Solution USP, 0.25%.
88-489      Procan SR (Procainamide    Parkedale Pharmaceuticals, Inc.
             Hydrochloride Extended-
             Release Tablets, USP), 1
             gram.
89-193      Methocarbamol and Aspirin  McNeil Consumer Healthcare, 7050
             Coated Tablets, 400 mg/    Camp Hill Rd., Fort Washington,
             325 mg.                    PA 19034-2299.
89-427      Dipyridamole Tablets USP,  Purepac Pharmaceutical Co., 200
             75 mg.                     Elmora Ave., Elizabeth, NJ
                                        07207.
89-614      Isoetharine Inhalation     AstraZeneca, L.P.
             Solution USP, 0.062%.
89-615      Isoetharine Inhalation     Do.
             Solution USP, 0.125%.

[[Page 58777]]

 
89-616      Isoetharine Inhalation     Do.
             Solution USP, 0.167%.
89-617      Isoetharine Inhalation     Do.
             Solution USP, 0.2%.
89-618      Isoetharine Inhalation     Do.
             Solution USP, 0.25%.
------------------------------------------------------------------------

    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 
October 10, 2000.

    Dated: September 12, 2000.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 00-24844 Filed 9-29-00; 8:45 am]
BILLING CODE 4160-01-F