Dacarbazine
Dacarbazine for Injection, USP
Approved
Approval ID
0d81315c-7021-4091-b703-ad135390c936
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 6, 2020
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
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 Code0143-9245
Application NumberANDA075812
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dacarbazine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 29, 2020
FDA Product Classification
INGREDIENTS (3)
DACARBAZINEActive
Quantity: 10 mg in 1 mL
Code: 7GR28W0FJI
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT