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Setid F7be6506 4d20 401e A0ff 02ad7c33158a Applno 50740 Form Injectable Liposomal Injection Dosage 50mg Vial - Drug Product Composition: Fungilin

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USFDA APPLICATION NUMBER - 50740 / DOSAGE - INJECTABLE, LIPOSOMAL;INJECTION - 50MG/VIAL

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPHOTERICIN B(UNII: 7XU7A7DROE)
(AMPHOTERICIN B - UNII:7XU7A7DROE)
AMPHOTERICIN B50mg in 12.5

Inactive Ingredients

Ingredient Name
Astellas Pharma US, Inc.
.ALPHA.-TOCOPHEROL(H4N855PNZ1)
CHOLESTEROL(97C5T2UQ7J)
DISTEAROYLPHOSPHATIDYLGLYCEROL, DL-(4271ZA8WXO)
HYDROGENATED SOYBEAN LECITHIN(H1109Z9J4N)
SODIUM SUCCINATE HEXAHYDRATE(U16QOD6C4E)
SUCROSE(C151H8M554)
WATER(059QF0KO0R)