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USFDA APPLICATION NUMBER - 20415 / DOSAGE - TABLET;ORAL - 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| MIRTAZAPINE(UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q) | MIRTAZAPINE | 45mg | 30mg | 15mg | 30mg | 15mg | 15mg | 30mg | 45mg |
Inactive Ingredients
| Ingredient Name | Organon USA Inc. | REMEDYREPACK INC. |
|---|---|---|
| ASPARTAME(Z0H242BBR1) | ||
| CITRIC ACID MONOHYDRATE(2968PHW8QP) | ||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | ||
| FERRIC OXIDE RED(1K09F3G675) | ||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||
| HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | ||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||
| LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | ||
| MAGNESIUM STEARATE(70097M6I30) | ||
| MANNITOL(3OWL53L36A) | ||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | ||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||
| SODIUM BICARBONATE(8MDF5V39QO) | ||
| STARCH, CORN(O8232NY3SJ) | ||
| SUCROSE(C151H8M554) | ||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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