MedPath

Zanosar

ZANOSAR (Streptozocin Sterile Powder)

Approved
Approval ID

15d161ed-9e7b-4c92-ba45-0556d2423e67

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 24, 2023

Manufacturers
FDA

Teva Parenteral Medicines, Inc.

DUNS: 794362533

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

streptozocin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0703-4636
Application NumberNDA050577
Product Classification
M
Marketing Category
C73594
G
Generic Name
streptozocin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 29, 2023
FDA Product Classification

INGREDIENTS (3)

STREPTOZOCINActive
Quantity: 100 mg in 1 mL
Code: 5W494URQ81
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT

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Zanosar - FDA Drug Approval Details