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USFDA APPLICATION NUMBER - 21590 / DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| CLOZAPINE(UNII: J60AR2IKIC) (CLOZAPINE - UNII:J60AR2IKIC) | CLOZAPINE | 200mg | 150mg | 100mg | 25mg | 12.5mg |
Inactive Ingredients
| Ingredient Name | Jazz Pharmaceuticals, Inc. | Teva Pharmaceuticals USA Inc |
|---|---|---|
| ASPARTAME(Z0H242BBR1) | ||
| CITRIC ACID MONOHYDRATE(2968PHW8QP) | ||
| CROSPOVIDONE (120 .MU.M)(68401960MK) | ||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | ||
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(905HNO1SIH) | ||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||
| MAGNESIUM STEARATE(70097M6I30) | ||
| mannitol(3OWL53L36A) | ||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||
| MINT(FV98Z8GITP) | ||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||
| SODIUM BICARBONATE(8MDF5V39QO) |
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