USFDA APPLICATION NUMBER - 21856 / DOSAGE - TABLET;ORAL - 80MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
FEBUXOSTAT(UNII: 101V0R1N2E) (FEBUXOSTAT - UNII:101V0R1N2E) | FEBUXOSTAT | 40mg |
Inactive Ingredients
Ingredient Name | Solco Healthcare US LLC | Mylan Pharmaceuticals Inc. | Avera McKennan Hospital | Indoco Remedies Limited | REMEDYREPACK INC. | AbbVie Inc. | Cardinal Health | Lannett Company, Inc. |
---|---|---|---|---|---|---|---|---|
ALUMINUM OXIDE(LMI26O6933) | ||||||||
ANHYDROUS LACTOSE(3SY5LH9PMK) | ||||||||
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||
croscarmellose sodium(M28OL1HH48) | ||||||||
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | ||||||||
D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||
FD&C BLUE NO. 1(H3R47K3TBD) | ||||||||
FD&C BLUE NO. 2(L06K8R7DQK) | ||||||||
FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||||
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P) | ||||||||
HYDROXYPROPYL CELLULOSE (1200000 WAMW)(U3JF91U133) | ||||||||
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | ||||||||
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | ||||||||
HYDROXYPROPYL CELLULOSE(RFW2ET671P) | ||||||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||||
lactose monohydrate(EWQ57Q8I5X) | ||||||||
MAGNESIUM STEARATE(70097M6I30) | ||||||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||
POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | ||||||||
POLYETHYLENE GLYCOL(3WJQ0SDW1A) | ||||||||
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||||
POLYVINYL ALCOHOL(532B59J990) | ||||||||
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | ||||||||
silicon dioxide(ETJ7Z6XBU4) | ||||||||
SODIUM LAURYL SULFATE(368GB5141J) | ||||||||
TALC(7SEV7J4R1U) | ||||||||
TITANIUM DIOXIDE(15FIX9V2JP) |
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