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Setid 3c327aa6 A790 4262 A79b 51856976d560 Applno 20781 Form Tablet Orally Disintegrating Oral Dosage 4mg - Drug Product Composition: Ondansetron

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$ API Ref.Price (USD/KG) : 1,370Xls

USFDA APPLICATION NUMBER - 20781 / DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 hydrochloride4mg

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)