USFDA APPLICATION NUMBER - 21999 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
---|---|---|
paliperidone(UNII: 838F01T721) (paliperidone - UNII:838F01T721) | paliperidone | 3mg |
Inactive Ingredients
Ingredient Name | Avera McKennan Hospital | REMEDYREPACK INC. |
---|---|---|
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K) | ||
CARNAUBA WAX(R12CBM0EIZ) | ||
CELLULOSE ACETATE(3J2P07GVB6) | ||
ferrosoferric oxide(XM0M87F357) | ||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||
hypromelloses(3NXW29V3WO) | ||
lactose monohydrate(EWQ57Q8I5X) | ||
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||
polyethylene glycols(3WJQ0SDW1A) | ||
povidone, unspecified(FZ989GH94E) | ||
povidones(FZ989GH94E) | ||
propylene glycol(6DC9Q167V3) | ||
sodium chloride(451W47IQ8X) | ||
STEARIC ACID(4ELV7Z65AP) | ||
titanium dioxide(15FIX9V2JP) | ||
triacetin(XHX3C3X673) |