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Setid 864f1c02 761f 4049 89fa 7aeec4118226 Applno 205580 Form Solution Intravenous Dosage 100mg 4ml 25mg Ml - Drug Product Composition: Treanda

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$ API Ref.Price (USD/KG) : 32,714Xls

USFDA APPLICATION NUMBER - 205580 / DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENDAMUSTINE HYDROCHLORIDE(UNII: 981Y8SX18M)
(BENDAMUSTINE - UNII:9266D9P3PQ)
BENDAMUSTINE HYDROCHLORIDE100mg

Inactive Ingredients

Ingredient Name
Apotex Corp
Eagle Pharmaceuticals, Inc
Teva Pharmaceuticals USA, Inc.
ALCOHOL(3K9958V90M)  
MONOTHIOGLYCEROL(AAO1P0WSXJ)
POLYETHYLENE GLYCOL 400(B697894SGQ) 
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)  
PROPYLENE GLYCOL(6DC9Q167V3) 
SODIUM HYDROXIDE (55X04QC32I)  
SODIUM HYDROXIDE(55X04QC32I)