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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064117

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NDA 064117 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 three 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. Four suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
Summary for 064117
Tradename:MITOMYCIN
Applicant:West-ward Pharms Int
Ingredient:mitomycin
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/VIAL
Approval Date:Apr 19, 1995TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/VIAL
Approval Date:Apr 19, 1995TE:APRLD:No

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