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Drug Product Composition: Amantadine

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$ API Ref.Price (USD/KG) : 17Xls

USFDA APPLICATION NUMBER - 209410 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 258MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMANTADINE(UNII: BF4C9Z1J53)
(AMANTADINE - UNII:BF4C9Z1J53)
AMANTADINE161mg | 258mg | 129mg | 193mg

Inactive Ingredients

Ingredient Name
Vertical Pharmaceuticals, LLC
CELLULOSE ACETATE(3J2P07GVB6)
COPOVIDONE K25-31(D9C330MD8B)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYSORBATE 80(6OZP39ZG8H)
PROPYLENE GLYCOL(6DC9Q167V3)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM CHLORIDE(451W47IQ8X)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)