USFDA APPLICATION NUMBER - 22117 / DOSAGE - TABLET;SUBLINGUAL - EQ 5MG BASE
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
Asenapine Maleate(UNII: CU9463U2E2) (Asenapine - UNII:JKZ19V908O) | Asenapine | 10mg | 5mg | 10mg | 5mg |
Inactive Ingredients
Ingredient Name | Alembic Pharmaceuticals Inc. | Organon Pharmaceuticals USA |
---|---|---|
BUTYLATED HYDROXYANISOLE(REK4960K2U) | ||
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K) | ||
gelatin(2G86QN327L) | ||
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14) | ||
mannitol(3OWL53L36A) | ||
POVIDONE K30(U725QWY32X) | ||
SODIUM STEARYL FUMARATE(7CV7WJK4UI) | ||
sucralose(96K6UQ3ZD4) |
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