An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075940
Company: HOSPIRA

Products on ANDA 075940

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DACARBAZINE	DACARBAZINE	200MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075940

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/18/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75940.ap.pdf

Therapeutic Equivalents for ANDA 075940

DACARBAZINE

INJECTABLE;INJECTION; 200MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DACARBAZINE	DACARBAZINE	200MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	075371	FRESENIUS KABI USA
DACARBAZINE	DACARBAZINE	200MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	075812	HIKMA
DACARBAZINE	DACARBAZINE	200MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	075940	HOSPIRA
DACARBAZINE	DACARBAZINE	200MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	075259	MEITHEAL

Top