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  Current Search:  betamethasone: 307, calcipotriene: 38, hydrate: 406  
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
PETERSBURG, FLORIDA" 10513 05-Oct-93 3M PHARMACEUTICALS "PIRBUTEROL ACETATE MANUFACTURED IN PITHIVIERS, CEDEX, FRANCE" 10514 08-Oct-93 LEO PHARMACEUTICAL PRODUCTS "CALCIPOTRIENE HYDRATE DRUG SUBSTANCE MANUFACTURED IN BALLERUP, DENMARK" 10515 08-Oct-93 LEO PHARMACEUTICAL "CALCIPOTRIENE CREAM DRUG PRODUCT MANUFACTURED IN BALLERUP, DENMARK" 10517 30-Sep-93 SIFAVITOR...

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http://www.fda.gov/cder/orange/appendix_a.txt
45, DIHYDROERGOTAMINE MESYLATE DACARBAZINE, DACARBAZINE DALGAN, DEZOCINE DALMANE, FLURAZEPAM HYDROCHLORIDE DANAZOL, DANAZOL DANOCRINE, DANAZOL DANTRIUM, DANTROLENE SODIUM DAPSONE, DAPSONE DARANIDE, DICHLORPHENAMIDE DARAPRIM, PYRIMETHAMINE DARBID, ISOPROPAMIDE IODIDE DARICON, OXYPHENCYCLIMINE HYDROCHLORIDE DARVOCET A500, ACETAMINOPHEN DARVOCET, ACETAMINOPHEN DARVOCET-N 100,...

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http://www.fda.gov/cder/dmf/text/4Q2003NEWTEXT.txt
CHINA." 16892 V 3-Sep-2003 ALTHEA TECHNOLOGIES INC "ASEPTIC FORMULATION, FILL, AND FINISH FACILITY IN SAN DIEGO, CA." 16893 III 15-Sep-2003 ERIE MOLDED PLASTICS INC "LID FOR DEODORANT AS MANUFACTURED IN ERIE, PA." 16894 II 5-Oct-2003 DIVIS LABORATORIES LTD "LEVITERACETAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA." 16895 IV 6-Oct-2003 FIRMENICH INC "NATURAL & ARTIFICIAL ORANGE FLAVOR...

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DOC
http://www.fda.gov/cder/dmf/xls/4Q2003NEWEXCEL.xls
Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003NEWEXCEL DMF # Type SUBMIT DATE HOLDER SUBJECT IV COGNIS DEUTSCHLAND GMBH CO KG MYRITOL(R) 318 PH AS MANUFACTURED IN DUESSELDORF, GERMANY
CHINA
II ROCHE DIAGNOSTICS GMBH TORASEMIDE AS...

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LIST OF APPROVED DRUGS FOR WHICH ADDITIONAL PEDIATRIC INFORMATION
DOCKET NO
Cardio-Renal Drug Products Betamethasone Corticosteroid responsive dermatoses
Anesthetic, Critical Care And Addiction Drug Products Bupropion Treatment of depression
Oncology Drug Products Calcipotriene Treatment of plaque psoriasis
Cardio-Renal Drug Products Clotrimazole/ Betamethasone Treatment of tinea pedis, tinea cruris, and tinea corporis...
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may20lst.PDF
No No Yes Yes Calcipotriene Treatment of plaque psoriasis No No No Yes Clobetasol Topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroidresponsive dermatoses No No No Yes Clotrimazole/ Betamethasone Treatment of tinea pedis, tinea cruris, and tinea corporis No No No Yes Doxepin Treatment of cutaneous histamine- mediated pruritus...

author: Unknown
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may20lst.PDF page 17


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FDA Drug Approvals List
Drug Approvals for March 1997 Definitions and Notes March 1997 Original New Drug Applications Original Application #: 020570 Approval Date: 28-MAR-97 Trade Name: QUADRAMET Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: CYTOGEN CORP Active Ingredient(s): SAMARIUM SM 153 EDTMP OTC/RX Status: RX Indication(s): For relief of pain in patients with confirmed...
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INTERFERING SUBSTANCES
Interfering Substances: Catecholamines Plasma, Physiological (in vivo) - No Effect: - Indomethacin - Ramipril - Increase: - Ajmaline - Aminophylline - Chlorpromazine - Clonidine - Cocoa - Cyclopropane - Diazoxide - Epinephrine - Ethanol - Ether - Isoproterenol - MAO inhibitors - Methyldopa - Nitroglycerin - Perphenazine - Phenothiazines - Phentolamine - Promethazine - Stress -...
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