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Setid F2f20b37 8bd4 4e8a B596 Be80b48ca2f1 Applno 20571 Form Injectable Injection Dosage 100mg 5ml 20mg Ml - Drug Product Composition: 042LAQ1IIS

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$ API Ref.Price (USD/KG) : 22,133Xls

USFDA APPLICATION NUMBER - 20571 / DOSAGE - INJECTABLE;INJECTION - 100MG/5ML (20MG/ML)

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRINOTECAN HYDROCHLORIDE(UNII: 042LAQ1IIS)
(IRINOTECAN - UNII:7673326042)
IRINOTECAN HYDROCHLORIDE20mg in 1

Inactive Ingredients

Ingredient Name
Actavis Pharma, Inc.
Armas Pharmaceuticals Inc.
Fresenius Kabi USA, LLC
Heritage Pharmaceuticals Inc.
Pharmacia and Upjohn Company LLC
Sagent Pharmaceuticals
Sandoz Inc
Sun Pharma Global FZE
Teva Parenteral Medicines, Inc.
Areva Pharmaceuticals,Inc.
Cipla Limited
NorthStar RxLLC
BluePoint Laboratories
HYDROCHLORIC ACID(QTT17582CB)    
LACTIC ACID(33X04XA5AT)   
LACTIC ACID, UNSPECIFIED FORM(33X04XA5AT)          
SODIUM HYDROXIDE(55X04QC32I)
SORBITOL(506T60A25R) 
WATER(059QF0KO0R)