You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 15, 2025

Details for New Drug Application (NDA): 215687

✉ Email this page to a colleague

« Back to Dashboard

NDA 215687 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 215687

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

Pharmacology for NDA: 215687

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 215687

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

Suppliers and Packaging for NDA: 215687

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MITOMYCIN	mitomycin	INJECTABLE;INJECTION	215687	ANDA	Sagent Pharmaceuticals	25021-250	25021-250-20	1 VIAL in 1 CARTON (25021-250-20) / 10 mL in 1 VIAL
MITOMYCIN	mitomycin	INJECTABLE;INJECTION	215687	ANDA	Sagent Pharmaceuticals	25021-251	25021-251-50	1 VIAL in 1 CARTON (25021-251-50) / 40 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5MG/VIAL
Approval Date:	Oct 20, 2021	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/VIAL
Approval Date:	Oct 20, 2021	TE:	AP	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.