Details for New Drug Application (NDA): 075371

NDA 075371 describes DACARBAZINE, which is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, Hikma, Hospira, and Meitheal, and is included in six NDAs. It is available from three suppliers. Additional details are available on the DACARBAZINE profile page.

The generic ingredient in DACARBAZINE is dacarbazine. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dacarbazine profile page.

Summary for 075371

Tradename:	DACARBAZINE
Applicant:	Fresenius Kabi Usa
Ingredient:	dacarbazine
Patents:	0

Pharmacology for NDA: 075371

Mechanism of Action

Alkylating Activity

Medical Subject Heading (MeSH) Categories for 075371

Antineoplastic Agents, Alkylating

Suppliers and Packaging for NDA: 075371

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	075371	ANDA	Fresenius Kabi USA, LLC	63323-127	63323-127-10	10 VIAL, SINGLE-DOSE in 1 TRAY (63323-127-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-127-00)
DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	075371	ANDA	Fresenius Kabi USA, LLC	63323-128	63323-128-20	10 VIAL, SINGLE-DOSE in 1 TRAY (63323-128-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-128-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/VIAL
Approval Date:	Aug 27, 1999	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/VIAL
Approval Date:	Aug 27, 1999	TE:	AP	RLD:	No

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