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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216732


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NDA 216732 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 216732
Tradename:MITOMYCIN
Applicant:Eugia Pharma
Ingredient:mitomycin
Patents:0
Pharmacology for NDA: 216732
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 216732
Alkylating Agents
Antibiotics, Antineoplastic
Cross-Linking Reagents
Nucleic Acid Synthesis Inhibitors
Suppliers and Packaging for NDA: 216732
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MITOMYCIN mitomycin INJECTABLE;INJECTION 216732 ANDA Eugia US LLC 55150-450 55150-450-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-450-01) / 10 mL in 1 VIAL, SINGLE-DOSE
MITOMYCIN mitomycin INJECTABLE;INJECTION 216732 ANDA Eugia US LLC 55150-451 55150-451-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-451-01) / 40 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5MG/VIAL
Approval Date:Oct 30, 2023TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength20MG/VIAL
Approval Date:Oct 30, 2023TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength40MG/VIAL
Approval Date:Oct 30, 2023TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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