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Drug Product Composition: Accutane

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$ API Ref.Price (USD/KG) : 1,941Xls

USFDA APPLICATION NUMBER - 21951 / DOSAGE - CAPSULE;ORAL - 35MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN(UNII: EH28UP18IF)
(ISOTRETINOIN - UNII:EH28UP18IF)
ISOTRETINOIN10mg | 20mg | 30mg | 40mg | 25mg | 35mg

Inactive Ingredients

Ingredient Name
Ranbaxy Laboratories Inc.
Sun Pharmaceutical Industries, Inc.
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C YELLOW NO. 5(I753WB2F1M)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L) 
GELATIN, UNSPECIFIED(2G86QN327L) 
PEG-32 HYDROGENATED PALM GLYCERIDES(G6EP177239)
POTASSIUM HYDROXIDE(WZH3C48M4T)
POVIDONES(FZ989GH94E) 
PROPYL GALLATE(8D4SNN7V92)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SODIUM HYDROXIDE(55X04QC32I)
SORBITAN MONOOLEATE(06XEA2VD56)
SOYBEAN OIL(241ATL177A)
TITANIUM DIOXIDE(15FIX9V2JP)