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Setid 7483423c 695c 4b62 B3cd 4e475f30b857 Applno 17579 Form Gel Topical Dosage 0 025 - Drug Product Composition: VELTIN-1

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$ API Ref.Price (USD/KG) : 2,007Xls

USFDA APPLICATION NUMBER - 17579 / DOSAGE - GEL;TOPICAL - 0.025%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRETINOIN(UNII: 5688UTC01R)
(TRETINOIN - UNII:5688UTC01R)
TRETINOIN0.25mg in 1 | 0.1mg in 1 | 1.0mg in 1 | 0.5mg in 1 | 0.25mg in 1

Inactive Ingredients

Ingredient Name
Ortho-McNeil Janssen Pharmaceuticals, Inc.
Spear Dermatology Products Inc
Rouses Point
Mylan Pharmaceuticals Inc.
ALCOHOL(3K9958V90M)  
BRUCINE SULFATE HEPTAHYDRATE(O900CDH328)   
BRUCINE SULFATE(KY7O12XPOQ)   
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)   
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)   
Hydroxypropyl Cellulose(RFW2ET671P)   
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)   
ISOPROPYL MYRISTATE(0RE8K4LNJS) 
Polyoxyl 40 Stearate(13A4J4NH9I) 
SORBIC ACID(X045WJ989B) 
STEARIC ACID(4ELV7Z65AP) 
Stearyl Alcohol(2KR89I4H1Y) 
TERT-BUTYL ALCOHOL(MD83SFE959)  
WATER(059QF0KO0R) 
XANTHAN GUM(TTV12P4NEE)