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Drug Product Composition: Tiagabine Hydrochloride

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USFDA APPLICATION NUMBER - 20646 / DOSAGE - TABLET;ORAL - 12MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIAGABINE HYDROCHLORIDE(UNII: DQH6T6D8OY)
(tiagabine - UNII:Z80I64HMNP)
TIAGABINE HYDROCHLORIDE4mg

Inactive Ingredients

Ingredient Name
Avera McKennan Hospital
CIMA LABS INC.
Lake Erie Medical & Surgial Supply DBA Quality Care Products LLC
ANHYDROUS LACTOSE(3SY5LH9PMK) 
ASCORBIC ACID(PQ6CK8PD0R)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)  
CROSPOVIDONE(68401960MK)  
CROSPOVIDONE, UNSPECIFIED(2S7830E561) 
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C YELLOW NO. 6(H77VEI93A8)  
HYDROGENATED SOYBEAN OIL(A2M91M918C) 
HYDROXYPROPYL CELLULOSE(RFW2ET671P)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH) 
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) 
HYPROMELLOSES(3NXW29V3WO)  
LACTOSE(J2B2A4N98G)  
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) 
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
TITANIUM DIOXIDE(15FIX9V2JP)