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    Setid 4e43152a D7e0 4501 83ea Cc723e0f8c61 Applno 21290 Form Tablet Oral Dosage 62 5mg - Drug Product Composition: Bosentan

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    Bosentan

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    $ API Ref.Price (USD/KG) : 2,645Xls

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    USFDA APPLICATION NUMBER - 21290 / DOSAGE - TABLET;ORAL - 62.5MG

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    bosentan(UNII: Q326023R30)
    (bosentan anhydrous - UNII:XUL93R30K2)     		bosentan anhydrous62.5mg | 125mg

    Inactive Ingredients

    Ingredient Name
    Lupin Pharmaceuticals, Inc.
    Alembic Pharmaceuticals Inc.
    Alembic Pharmaceuticals Limited
    Amneal Pharmaceuticals LLC
    Cipla USA Inc.
    CoTherix, Inc.
    Sun Pharmaceutical Industries, Inc.
    Zydus Pharmaceuticals USA Inc.
    Alvogen Inc.
    CETYL ALCOHOL(936JST6JCN)        
    CROSCARMELLOSE SODIUM(M28OL1HH48)        
    ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)   
    ETHYLCELLULOSES(7Z8S9VYZ4B)       
    FERRIC OXIDE RED(1K09F3G675)
    FERRIC OXIDE YELLOW(EX438O2MRT)
    GLYCERYL BEHENATE/EICOSADIOATE(73CJJ317SR)       
    GLYCERYL DIBEHENATE(R8WTH25YS2)   
    hypromellose, unspecified(3NXW29V3WO)     
    HYPROMELLOSES(3NXW29V3WO)     
    MAGNESIUM STEARATE(70097M6I30)
    POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)        
    POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)        
    POVIDONE K30(U725QWY32X)      
    POVIDONE K90(RDH86HJV5Z)       
    POVIDONE(FZ989GH94E)      
    POVIDONE, UNSPECIFIED(FZ989GH94E)        
    SODIUM LAURYL SULFATE(368GB5141J)        
    SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B)        
    SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)  
    SODIUM STARCH GLYCOLATE TYPE B POTATO(27NA468985)        
    starch, corn(O8232NY3SJ)  
    STARCH, PREGELATINIZED CORN(O8232NY3SJ)       
    talc(7SEV7J4R1U)
    TITANIUM DIOXIDE(15FIX9V2JP)
    TRIACETIN(XHX3C3X673)