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USFDA APPLICATION NUMBER - 204447 / DOSAGE - TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| VORTIOXETINE HYDROBROMIDE(UNII: TKS641KOAY) (VORTIOXETINE - UNII:3O2K1S3WQV) | VORTIOXETINE | 20mg | 15mg | 10mg | 5mg |
Inactive Ingredients
| Ingredient Name | Avera McKennan Hospital | Takeda Pharmaceuticals America, Inc. | REMEDYREPACK INC. |
|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||
| FERRIC OXIDE RED(1K09F3G675) | |||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||
| HYDROXYPROPYL CELLULOSE (120000 MW)(UKE75GEA7F) | |||
| HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F) | |||
| HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | |||
| HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | |||
| MAGNESIUM STEARATE(70097M6I30) | |||
| MANNITOL(3OWL53L36A) | |||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||
| POLYETHYLENE GLYCOL 400(B697894SGQ) | |||
| SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B) | |||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||
| TITANIUM DIOXIDE(15FIX9V2JP) |
