
USFDA APPLICATION NUMBER - 21071 / DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| ROSIGLITAZONE MALEATE(UNII: KX2339DP44) (ROSIGLITAZONE - UNII:05V02F2KDG) | ROSIGLITAZONE MALEATE | 8mg | 4mg |
Inactive Ingredients
| Ingredient Name | Cardinal Health | GlaxoSmithKline Inc | GlaxoSmithKline LLC |
|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||
| FERRIC OXIDE RED(1K09F3G675) | |||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||
| HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82) | |||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||
| MAGNESIUM STEARATE(70097M6I30) | |||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||
| POLYETHYLENE GLYCOL 3000(SA1B764746) | |||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||
| TALC(7SEV7J4R1U) | |||
| TITANIUM DIOXIDE(15FIX9V2JP) | |||
| TRIACETIN(XHX3C3X673) |