
USFDA APPLICATION NUMBER - 21856 / DOSAGE - TABLET;ORAL - 40MG
| 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) |