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Setid 1d1ef482 12b0 4590 9d2e 17b377b0e26d Applno 21131 Form Solution Intravenous Dosage 600mg 300ml 2mg Ml - Drug Product Composition: HY-10394

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$ API Ref.Price (USD/KG) : 614Xls

USFDA APPLICATION NUMBER - 21131 / DOSAGE - SOLUTION;INTRAVENOUS - 600MG/300ML (2MG/ML)

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LINEZOLID(UNII: ISQ9I6J12J)
(LINEZOLID - UNII:ISQ9I6J12J)
LINEZOLID600mg in 300

Inactive Ingredients

Ingredient Name
Hospira, Inc.
Teva Parenteral Medicines, Inc.
Fresenius Kabi Norge As
Mylan Institutional LLC
ANHYDROUS CITRIC ACID(XF417D3PSL)  
CITRIC ACID MONOHYDRATE(2968PHW8QP)  
DEXTROSE MONOHYDRATE(LX22YL083G)  
DEXTROSE, UNSPECIFIED FORM(IY9XDZ35W2)  
HYDROCHLORIC ACID(QTT17582CB)  
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)  
SODIUM HYDROXIDE(55X04QC32I)  
TRISODIUM CITRATE DIHYDRATE(B22547B95K)   
WATER(059QF0KO0R)