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Setid 3309d312 4696 4cfd A231 75ea13c0bdff Applno 17955 Form Gel Topical Dosage 0 01 - Drug Product Composition: VELTIN-1

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

USFDA APPLICATION NUMBER - 17955 / DOSAGE - GEL;TOPICAL - 0.01%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tretinoin(UNII: 5688UTC01R)
(Tretinoin - UNII:5688UTC01R)
Tretinoin0.25mg in 1 | 0.5mg in 1 | 1mg in 1 | 0.1mg in 1 | 0.25mg in 1

Inactive Ingredients

Ingredient Name
Ortho-McNeil Janssen Pharmaceuticals, Inc.
Spear Dermatology Products Inc
Rouses Point
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)  
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)