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Drug Product Composition: Fosnetupitant Chloride

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USFDA APPLICATION NUMBER - 210493 / DOSAGE - SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOSNETUPITANT(UNII: T672P80L2S)
(FOSNETUPITANT - UNII:T672P80L2S)
FOSNETUPITANT260mg | 260mg in 20 | 260mg in 20
NETUPITANT(UNII: 7732P08TIR)
(NETUPITANT - UNII:7732P08TIR)
NETUPITANT300mg
PALONOSETRON HYDROCHLORIDE(UNII: 23310D4I19)
(PALONOSETRON - UNII:5D06587D6R)
PALONOSETRON0.28mg | 0.28mg in 20 | 0.28mg in 20
PALONOSETRON(UNII: 5D06587D6R)
(PALONOSETRON - UNII:5D06587D6R)
PALONOSETRON0.5mg

Inactive Ingredients

Ingredient Name
Helsinn Therapeutics (U.S.), Inc.
BUTYLATED HYDROXYANISOLE(REK4960K2U)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES(U72Q2I8C85)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
EDETATE DISODIUM(7FLD91C86K)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
GELATIN(2G86QN327L)
GLYCERIN(PDC6A3C0OX)
HYDROCHLORIC ACID(QTT17582CB)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
POLYGLYCERYL-3 DIOLEATE(D08AL46IU2)
POVIDONE K30(U725QWY32X)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
SORBITOL(506T60A25R)
SUCROSE LAURATE(05Q7CD0E49)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)