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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

NDC Product Code0143-9245
Application NumberANDA075812
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMay 29, 2020
Generic NameDacarbazine

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
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Dacarbazine - FDA Approval | MedPath