Details for New Drug Application (NDA): 064117

NDA 064117 describes MITOMYCIN, which is a drug marketed by Accord Hlthcare, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, and Rk Pharma, and is included in twelve NDAs. It is available from ten suppliers. Additional details are available on the MITOMYCIN profile page.

The generic ingredient in MITOMYCIN is mitomycin. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mitomycin profile page.

Summary for 064117

Tradename:	MITOMYCIN
Applicant:	Hikma
Ingredient:	mitomycin
Patents:	0

Pharmacology for NDA: 064117

Mechanism of Action

Alkylating Activity

Medical Subject Heading (MeSH) Categories for 064117

Alkylating Agents

Antibiotics, Antineoplastic

Cross-Linking Reagents

Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 064117

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MITOMYCIN	mitomycin	INJECTABLE;INJECTION	064117	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9135	0143-9135-01	1 VIAL in 1 BOX (0143-9135-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
MITOMYCIN	mitomycin	INJECTABLE;INJECTION	064117	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9136	0143-9136-01	1 VIAL in 1 BOX (0143-9136-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	5MG/VIAL
Approval Date:	Apr 19, 1995	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/VIAL
Approval Date:	Apr 19, 1995	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	40MG/VIAL
Approval Date:	Jun 2, 1999	TE:	AP	RLD:	No

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