Last Updated: September 24, 2026

Details for New Drug Application (NDA): 064106

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NDA 064106 describes MITOMYCIN, which is a drug marketed by Accord Hlthcare, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, Meitheal, and Rk Pharma, and is included in twelve NDAs. It is available from eleven suppliers. Additional details are available on the MITOMYCIN profile page.

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

Summary for 064106

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

Medical Subject Heading (MeSH) Categories for 064106

Alkylating Agents
Antibiotics, Antineoplastic
Cross-Linking Reagents
Nucleic Acid Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	20MG/VIAL
Approval Date:	Nov 29, 1995	TE:		RLD:	No

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