USFDA APPLICATION NUMBER - 21875 / DOSAGE - TABLET;ORAL - 50MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
ARMODAFINIL(UNII: V63XWA605I) (ARMODAFINIL - UNII:V63XWA605I) | ARMODAFINIL | 50mg | 250mg |
Inactive Ingredients
Ingredient Name | Breckenridge Pharmaceutical, Inc. | A-S Medication Solutions LLC | Actavis Pharma, Inc. | KAISER FOUNDATION HOSPITALS | Lake Erie Medical DBA Quality Care Products LLC | Aurobindo Pharma Limited | Bryant Ranch Prepack | Direct_Rx | PD-Rx Pharmaceuticals, Inc. | Preferred Pharmacceuticals Inc. | Preferred Pharmaceuticals Inc. | Preferred Pharmaceuticals, Inc. | Lupin Pharmaceuticals, Inc. | AUROBINDO PHARMA LIMITED |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
ANHYDROUS LACTOSE(3SY5LH9PMK) | ||||||||||||||
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||||||||
CROSCARMELLOSE SODIUM(M28OL1HH48) | ||||||||||||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||||||||||
MAGNESIUM STEARATE(70097M6I30) | ||||||||||||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||||||||
POVIDONE K12(333AG72FWJ) | ||||||||||||||
POVIDONE K29/32(390RMW2PEQ) | ||||||||||||||
POVIDONE K30(U725QWY32X) | ||||||||||||||
POVIDONE(FZ989GH94E) | ||||||||||||||
POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||||||||||||
POVIDONES(FZ989GH94E) | ||||||||||||||
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||||||||||||||
SODIUM STEARYL FUMARATE(7CV7WJK4UI) | ||||||||||||||
starch, corn(O8232NY3SJ) |
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