Last Updated: November 8, 2026

Details for New Drug Application (NDA): 064180

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NDA 064180 describes MITOMYCIN, which is a drug marketed by Accord Hlthcare, Adaptis, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, and Meitheal, 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 064180

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

Medical Subject Heading (MeSH) Categories for 064180

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5MG/VIAL
Approval Date:	Dec 23, 1999	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/VIAL
Approval Date:	Dec 23, 1999	TE:	AP	RLD:	No

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