Make Better Decisions

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Medtronic
Moodys
Federal Trade Commission
Fuji
Healthtrust
Boehringer Ingelheim
Citi
McKesson
Harvard Business School

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064144

« Back to Dashboard

NDA 064144 describes MITOMYCIN, which is a drug marketed by Accord Hlthcare, Hospira, Mylan Labs Ltd, and West-ward Pharms Int, and is included in six NDAs. It is available from two 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. Three suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
Summary for 064144
Tradename:MITOMYCIN
Applicant:Accord Hlthcare
Ingredient:mitomycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 064144
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 064144
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MITOMYCIN mitomycin INJECTABLE;INJECTION 064144 ANDA Accord Healthcare Inc 16729-108 16729-108-11 1 VIAL in 1 BOX, UNIT-DOSE (16729-108-11) > 40 mL in 1 VIAL
MITOMYCIN mitomycin INJECTABLE;INJECTION 064144 ANDA Accord Healthcare Inc 16729-115 16729-115-05 1 VIAL in 1 CARTON (16729-115-05) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/VIAL
Approval Date:Apr 30, 1998TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/VIAL
Approval Date:Apr 30, 1998TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/VIAL
Approval Date:Aug 11, 2009TE:APRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Federal Trade Commission
QuintilesIMS
Julphar
Merck
Dow
Chinese Patent Office
Harvard Business School
Covington

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 verifification 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.

botpot