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

Last Updated: November 24, 2024

Details for New Drug Application (NDA): 203386


✉ Email this page to a colleague

« Back to Dashboard


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 ActionAlkylating Activity
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:RXDosage:INJECTABLE;INJECTIONStrength40MG/VIAL
Approval Date:Oct 13, 2017TE:APRLD: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. 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.