Dacarbazine
Dacarbazine for Injection, USP
Approved
Approval ID
b6b97e41-5f15-498c-abfb-d8443ea4d216
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DACARBAZINE
PRODUCT DETAILS
NDC Product Code63323-128
Application NumberANDA075371
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateOctober 20, 2022
Generic NameDACARBAZINE
INGREDIENTS (3)
CITRIC ACID MONOHYDRATEInactive
Quantity: 10 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
DACARBAZINEActive
Quantity: 10 mg in 1 mL
Code: 7GR28W0FJI
Classification: ACTIB
MANNITOLInactive
Quantity: 3.75 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
DACARBAZINE
PRODUCT DETAILS
NDC Product Code63323-127
Application NumberANDA075371
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateOctober 20, 2022
Generic NameDACARBAZINE
INGREDIENTS (3)
CITRIC ACID MONOHYDRATEInactive
Quantity: 10 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
MANNITOLInactive
Quantity: 5 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
DACARBAZINEActive
Quantity: 10 mg in 1 mL
Code: 7GR28W0FJI
Classification: ACTIB