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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 203386

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NDA 203386 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 203386

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

Pharmacology for NDA: 203386

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 203386

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

Suppliers and Packaging for NDA: 203386

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MITOMYCIN	mitomycin	INJECTABLE;INJECTION	203386	ANDA	Archis Pharma LLC	72819-154	72819-154-04	1 VIAL in 1 CARTON (72819-154-04) / 80 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	40MG/VIAL
Approval Date:	Oct 13, 2017	TE:	AP	RLD:	No

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