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Setid 5587db37 F21a 4a39 A319 E1077032ced9 Applno 50724 Form Injectable Lipid Complex Injection Dosage 5mg Ml - Drug Product Composition: Liposomal Amphotericin B

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USFDA APPLICATION NUMBER - 50724 / DOSAGE - INJECTABLE, LIPID COMPLEX;INJECTION - 5MG/ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPHOTERICIN B(UNII: 7XU7A7DROE)
(AMPHOTERICIN B - UNII:7XU7A7DROE)
AMPHOTERICIN B5mg in 1
DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-(UNII: U86ZGC74V5)
(DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- - UNII:U86ZGC74V5)
DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-3.4mg in 1
DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-(UNII: BI71WT9P3R)
(DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- - UNII:BI71WT9P3R)
DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-1.5mg in 1

Inactive Ingredients

Ingredient Name
Leadiant Biosciences, Inc.
SODIUM CHLORIDE(451W47IQ8X)
WATER(059QF0KO0R)