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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) | FOSNETUPITANT | 260mg | 260mg in 20 | 260mg in 20 |
| NETUPITANT(UNII: 7732P08TIR) (NETUPITANT - UNII:7732P08TIR) | NETUPITANT | 300mg |
| PALONOSETRON HYDROCHLORIDE(UNII: 23310D4I19) (PALONOSETRON - UNII:5D06587D6R) | PALONOSETRON | 0.28mg | 0.28mg in 20 | 0.28mg in 20 |
| PALONOSETRON(UNII: 5D06587D6R) (PALONOSETRON - UNII:5D06587D6R) | PALONOSETRON | 0.5mg |
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) |
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