USFDA APPLICATION NUMBER - 22522 / DOSAGE - TABLET;ORAL - 500MCG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
roflumilast(UNII: 0P6C6ZOP5U) (roflumilast - UNII:0P6C6ZOP5U) | roflumilast | 500ug |
Inactive Ingredients
Ingredient Name | Torrent Pharmaceuticals Limited | Solco Healthcare US, LLC. | Strides Pharma Science Limited | ALLERGAN, INC. | Cardinal Health |
---|---|---|---|---|---|
CARBOXYMETHYLCELLULOSE CALCIUM(UTY7PDF93L) | |||||
COPOVIDONE K25-31(D9C330MD8B) | |||||
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | |||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||
magnesium stearate(70097M6I30) | |||||
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | |||||
povidone(FZ989GH94E) | |||||
POVIDONE, UNSPECIFIED(FZ989GH94E) | |||||
SODIUM STEARYL FUMARATE(7CV7WJK4UI) | |||||
STARCH, CORN(O8232NY3SJ) |
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