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Documents 1-11 out of 11 found
  Current Search:  tri: 33999, luma: 74, fluocinolone: 74, acetonide: 161, hydroquinone: 126, tretinoin: 513  
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Prescription and OTC Drug Product List 1/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA KV PHARM 500MG/15ML;7.5MG/15ML N40366 001 JAN 23, 2002 JAN NEWA AMPHOTERICIN B INJECTABLE, LI COMPLEX; INJECTION ABELCET -A- + ELAN PHARMS 5MG/ML N50724 001 NOV 20, 1995 JAN CAHN -D- + LIPOSOME 5MG/ML N50724 001 NOV 20, 1995 JAN...
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Galderma
Triple drug therapy like Tri-Luma™ Cream is of definite benefit." Tri-Luma™ Cream contains 4.0% hydroquinone, 0.05% tretinoin, and 0.01% fluocinolone acetonide in a cream formulation that is applied topically to affected areas of the skin
Tri-Luma™ Cream was compared for safety and efficacy in clinical trials to formulations...
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C:\Data\540\NDA\21112 TRI-LUMA CREAM\Approval letter with labeling \ Jan18-2002 TRI-LUMA-.doc
NDA 21- 112 Page 4 TRI- LUMA™ Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) For External Use Only Not for Ophthalmic Use Rx only DESCRIPTION TRI- LUMA™ Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) contains fluocinolone acetonide, USP, hydroquinone, USP, and tretinoin, USP, in a...

author: Victoria Lutwak
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C:\Data\540\NDA\21112 TRI-LUMA CREAM\Approval letter with labeling \ Jan18-2002 TRI-LUMA-.doc page 1


author: Victoria Lutwak
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http://www.fda.gov/cder/orange/appendix_a.txt
2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO, SECRETIN...

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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
4Q2003 TYPE2ACTIVETEXT DMF # SUBMIT DATE HOLDER SUBJECT 131 01-Jan-40 CENTRAL SOYA SOYBEAN STEROL PRODUCTS 183 29-Feb-52 INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 191 24-Jan-56 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) 240 11-Jan-57 PHARMACIA & UPJOHN 19-NOR-ETHINYLTESTOSTERONE 281 21-Nov-57 UNIMED PHARMACEUTICALS INC 2 HYDROXY...

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OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004
- INJECTION Approved 8/13/2003- METHADONE HYDROCHLORIDE 15MG,20MG,30MG,40MG - 03P-0119/CP1 LACHMAN CONSULTANT SERVICES - TABLETS USP Pending 5/13/2003- VENLAFAXINE HYDROCHLORIDE 37.5MG, 75MG, 150MG - 03P-0159/CP1 LACHMAN CONSULTANT SERVICES - EXTENDED RELEASE TABLETS Pending 4/16/2003- DIVALPROEX SODIUM 1000 MG - 03P-0178/CP1 LACHMAN CONSULTANT SERVICES - EXTENDED RELEASE TABLETS...
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OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004
- INJECTION Approved 8/13/2003- ESTROPIPATE 1.2 mg - 02P-0141/CP1 WOMEN FIRST HEALTHCARE - TABLETS Approved 9/24/2002- ETHINYL ESTRADIOL 0.035 MG NORETHINDRONE 0.4 MG - 99P-1150/CP1 KIRKLAND & ELLIS - TABLET; CHEWABLE Approved 4/14/2000- FAMOTIDINE 10MG - 00P-1422/CP1 YAMANOUCHI PHARMA TECHNOLOGIES - TABLET; ORALLY DISINTEGRATING Approved 4/17/2001- FENOFIBRATE 107 mg - 02P-0148/CP1...
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C:\Data\540\NDA\21112 TRI-LUMA CREAM\Approval letter with labeling \ Jan18-2002 TRI-LUMA-.doc page 2


author: Victoria Lutwak
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Prescription and OTC Drug Product List 6/2002
-D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003 TYPE2ACTIVEEXCEL DMF # SUBMIT DATE HOLDER SUBJECT CENTRAL SOYA SOYBEAN STEROL PRODUCTS INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE ...

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