USFDA APPLICATION NUMBER - 21355 / DOSAGE - TABLET;ORAL - 0.5MG;1MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
DROSPIRENONE(UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25) | DROSPIRENONE | 0.5mg | 0.25mg |
ESTRADIOL(UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) | ESTRADIOL | 1mg | 0.5mg |
Inactive Ingredients
Ingredient Name | Bayer HealthCare Pharmaceuticals Inc. |
---|---|
FERRIC OXIDE RED(1K09F3G675) | |
FERRIC OXIDE YELLOW(EX438O2MRT) | |
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |
MAGNESIUM STEARATE(70097M6I30) | |
POLYETHYLENE GLYCOL 6000(30IQX730WE) | |
POVIDONE K25(K0KQV10C35) | |
STARCH, CORN(O8232NY3SJ) | |
TALC(7SEV7J4R1U) | |
TITANIUM DIOXIDE(15FIX9V2JP) |
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