USFDA APPLICATION NUMBER - 21590 / DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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