Dacarbazine
Dacarbazine for Injection, USP
Approved
Approval ID
26e91082-7698-4680-beab-07c47802f0f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2020
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.
Dacarbazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0703-5075
Application NumberANDA075259
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dacarbazine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 28, 2020
FDA Product Classification
INGREDIENTS (3)
DACARBAZINEActive
Quantity: 200 mg in 20 mL
Code: 7GR28W0FJI
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT