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Last Updated: November 22, 2024

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 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 202670
Tradename:MITOMYCIN
Applicant:Rk Pharma
Ingredient:mitomycin
Patents:0
Pharmacology for NDA: 202670
Mechanism of ActionAlkylating Activity
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 Archis Pharma LLC 72819-152 72819-152-95 1 VIAL in 1 CARTON (72819-152-95) / 10 mL in 1 VIAL
MITOMYCIN mitomycin INJECTABLE;INJECTION 202670 ANDA Archis Pharma LLC 72819-152 72819-152-05 1 VIAL in 1 CARTON (72819-152-05) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/VIAL
Approval Date:Oct 13, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/VIAL
Approval Date:Oct 13, 2017TE:APRLD:No

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