USFDA APPLICATION NUMBER - 20781 / DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
---|---|---|
ondansetron hydrochloride(UNII: NMH84OZK2B) (ondansetron - UNII:4AF302ESOS) | ondansetron hydrochloride | 4mg |
Inactive Ingredients
Ingredient Name | GlaxoSmithKline LLC | Cardinal Health | Novartis Pharmaceuticals Corporation | REMEDYREPACK INC. |
---|---|---|---|---|
ANHYDROUS CITRIC ACID(XF417D3PSL) | ||||
ASPARTAME(Z0H242BBR1) | ||||
FERRIC OXIDE YELLOW(EX438O2MRT) | ||||
GELATIN(2G86QN327L) | ||||
GELATIN, UNSPECIFIED(2G86QN327L) | ||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | ||||
MAGNESIUM STEARATE(70097M6I30) | ||||
MANNITOL(3OWL53L36A) | ||||
METHYLPARABEN SODIUM(CR6K9C2NHK) | ||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||
PROPYLPARABEN SODIUM(625NNB0G9N) | ||||
SODIUM BENZOATE(OJ245FE5EU) | ||||
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR) | ||||
SORBITOL(506T60A25R) | ||||
STARCH, CORN(O8232NY3SJ) | ||||
TITANIUM DIOXIDE(15FIX9V2JP) | ||||
TRIACETIN(XHX3C3X673) | ||||
WATER(059QF0KO0R) |
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