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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 202670

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NDA 202670 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 are seven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the mitomycin profile page.

Summary for 202670

Tradename:	MITOMYCIN
Applicant:	Rk Pharma
Ingredient:	mitomycin
Patents:	0

Pharmacology for NDA: 202670

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 202670

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

Suppliers and Packaging for NDA: 202670

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MITOMYCIN	mitomycin	INJECTABLE;INJECTION	202670	ANDA	Bryant Ranch Prepack	71335-2927	71335-2927-1	1 VIAL in 1 CARTON (71335-2927-1) / 10 mL in 1 VIAL
MITOMYCIN	mitomycin	INJECTABLE;INJECTION	202670	ANDA	Bryant Ranch Prepack	72162-2464	72162-2464-2	1 VIAL in 1 CARTON (72162-2464-2) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5MG/VIAL
Approval Date:	Oct 13, 2017	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/VIAL
Approval Date:	Oct 13, 2017	TE:	AP	RLD:	No

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