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USFDA APPLICATION NUMBER - 22206 / DOSAGE - CAPSULE;ORAL - 8MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| SILODOSIN(UNII: CUZ39LUY82) (SILODOSIN - UNII:CUZ39LUY82) | SILODOSIN | 4mg | 8mg |
Inactive Ingredients
| Ingredient Name | AvKARE | Alembic Pharmaceuticals Inc. | Lupin Pharmaceuticals, Inc. | MSN LABORATORIES PRIVATE LIMITED | Novadoz Pharmaceuticals LLC | PD-Rx Pharmaceuticals, Inc. |
|---|---|---|---|---|---|---|
| ALCOHOL(3K9958V90M) | ||||||
| AMMONIA(5138Q19F1X) | ||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | ||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||||||
| GELATIN(2G86QN327L) | ||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | ||||||
| ISOPROPYL ALCOHOL(ND2M416302) | ||||||
| MAGNESIUM ALUMINOMETASILICATE TYPE IA(7LVU907546) | ||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||
| MANNITOL(3OWL53L36A) | ||||||
| POLYSORBATE 80(6OZP39ZG8H) | ||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | ||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||||
| SHELLAC(46N107B71O) | ||||||
| SHELLAC(MB5IUD6JUA) | ||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||
| SODIUM STEARYL FUMARATE(7CV7WJK4UI) | ||||||
| STARCH, CORN(O8232NY3SJ) | ||||||
| SUCROSE(C151H8M554) | ||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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