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Last Updated: December 26, 2024

Details for New Drug Application (NDA): 211269

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NDA 211269 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 211269

Tradename:	MITOMYCIN
Applicant:	Fresenius Kabi Usa
Ingredient:	mitomycin
Patents:	0

Medical Subject Heading (MeSH) Categories for 211269

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:	Apr 5, 2024	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/VIAL
Approval Date:	Apr 5, 2024	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	40MG/VIAL
Approval Date:	Apr 5, 2024	TE:	AP	RLD:	No

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