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FDA Approval

Zanosar

CompanyESTEVE PHARMACEUTICALS, S.A. (DUNS: 460023922)

Effective Date

April 3, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Streptozocin(1 g in 10 mL)

Products (1)

Zanosar

NDC Product Code

68118-100

Route of Administration

INTRAVENOUS

Effective Date

April 3, 2023

Ingredients

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

StreptozocinActive

Code: 5W494URQ81Class: ACTIBQuantity: 1 g in 10 mL

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label

carton label

HEALTH CARE PROVIDER LETTER SECTION

Dear Health Care Provider Letter

HOW SUPPLIED SECTION

How supplied

NDC 68118-100-01: Each vial contains 1g Streptozocin Powder for concentrate for solution for infusion. Each carton contains 1 vial.

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