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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 - 20MG

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
Teva Pharmaceuticals USA, Inc.
Ranbaxy Laboratories Inc.
Sun Pharmaceutical Industries, Inc.
ALPHA-TOCOPHEROL(H4N855PNZ1)  
AMMONIA(5138Q19F1X)  
BUTYLATED HYDROXYANISOLE(REK4960K2U)  
D&C RED NO. 7(ECW0LZ41X8)  
D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6)  
DIMETHICONE 350(2Y53S6ATLU)  
EDETATE DISODIUM(7FLD91C86K)  
FD&C BLUE NO. 1 ALUMINUM LAKE(J9EQA3S2JM)  
FD&C BLUE NO. 1(H3R47K3TBD) 
FD&C BLUE NO. 2(L06K8R7DQK) 
FD&C BLUE NO. 2--ALUMINUM LAKE(4AQJ3LG584)  
FD&C RED NO. 40(WZB9127XOA)  
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) 
HYDROGENATED SOYBEAN OIL(A2M91M918C)  
PEG-32 HYDROGENATED PALM GLYCERIDES(G6EP177239) 
POLYSORBATE 80(6OZP39ZG8H)  
POTASSIUM HYDROXIDE(WZH3C48M4T) 
POVIDONES(FZ989GH94E)  
PROPYL GALLATE(8D4SNN7V92) 
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICA, TRIMETHYLSILYL CAPPED(VU10KU4B9S)  
SODIUM HYDROXIDE(55X04QC32I) 
SORBITAN MONOOLEATE(06XEA2VD56) 
SOYBEAN OIL(241ATL177A)
TITANIUM DIOXIDE(15FIX9V2JP)
WHITE WAX(7G1J5DA97F)