USFDA APPLICATION NUMBER - 21875 / DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
ARMODAFINIL(UNII: V63XWA605I) (ARMODAFINIL - UNII:V63XWA605I) | ARMODAFINIL | 50mg | 250mg |
Inactive Ingredients
Ingredient Name | 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. |
---|---|---|---|---|---|---|---|---|---|---|
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) | ||||||||||
POVIDONES(FZ989GH94E) | ||||||||||
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||||||||||
SODIUM STEARYL FUMARATE(7CV7WJK4UI) | ||||||||||
STARCH, CORN(O8232NY3SJ) |
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