
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) |