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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Baxter
Deloitte
McKinsey
Colorcon
Cipla
Cerilliant
Cantor Fitzgerald
Harvard Business School

Generated: July 22, 2018

DrugPatentWatch Database Preview

Drug Master Files for: mitoxantrone

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mitoxantrone Drug Master Files

DMF No. Status Type Submission Date Holder Subject
5203 I II 1/3/1984 HEINRICH MACK NACHF MITOXANTRONE DIHYDROCHLORIDE
10858 I II 4/11/1994 CIPLA LTD MITOXANTRONE HYDROCHLORIDE
12046 I II 7/19/1996 SYNTHESIA AS MITOXANTRONE HYDROCHLORIDE USP
12262 A II 12/11/1996 CHONGQING CARELIFE PHARMACEUTICAL CO LTD MITOXANTRONE HYDROCHLORIDE USP
DMF No. Status Type Submission Date Holder Subject

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Drug Master File Glossary

STATUS OF DMFS

  • A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
  • I = Inactive
  • N = Not an assigned number
  • P = DMF Pending Filing Review

TYPES OF DMFs

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III Packaging Material
  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V FDA Accepted Reference Information

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Farmers Insurance
Colorcon
AstraZeneca
McKinsey
Cerilliant
Argus Health
Accenture

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