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USFDA APPLICATION NUMBER - 20605 / DOSAGE - SOLUTION;ORAL - EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 | 4mg | 8mg | 4mg in 5 |
| ONDANSETRON(UNII: 4AF302ESOS) (ONDANSETRON - UNII:4AF302ESOS) | ONDANSETRON | 4mg | 8mg |
Inactive Ingredients
| Ingredient Name | GlaxoSmithKline Inc | GlaxoSmithKline LLC |
|---|---|---|
| ANHYDROUS CITRIC ACID(XF417D3PSL) | ||
| ASPARTAME(Z0H242BBR1) | ||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||
| 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) |
