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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Farmers Insurance
US Department of Justice
Fish and Richardson
US Army
Argus Health

Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064144

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NDA 064144 describes MITOMYCIN, which is a drug marketed by Hospira, West-ward Pharms Int, and Accord Hlthcare, and is included in four 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 NDA: 064144

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
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
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

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim
Fish and Richardson
Harvard Business School

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