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Generated: February 18, 2018

DrugPatentWatch Database Preview

Drug Master Files for: mycophenolate

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DMF No. Status Type Submission Date Holder Subject
16406AII1/20/2003BIOCON LTDMYCOPHENOLATE MOFETIL
18494AII7/11/2005CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDMYCOPHENOLATE MOFETIL USP
18936AII11/7/2005LEK PHARMACEUTICALS DDMYCOPHENOLATE MOFETIL
18989III11/28/2005IVAX PHARMACEUTICALS SROMYCOPHENOLATE MOFETIL USP
19231AII3/7/2006CONCORD BIOTECH LTDMYCOPHENOLATE MOFETIL USP
20072AII12/20/2006TEVA PHARMACEUTICAL INDUSTRIES LTDMYCOPHENOLATE MOFETIL DRUG SUBSTANCE
20655AII7/2/2007SHANDONG NEW TIME PHARMACEUTICAL CO LTDMYCOPHENOLATE MOFETIL
20679III11/7/2007CIPLA LTDMYCOPHENOLATE MOFETIL BP/PH. EUR.
20758III8/7/2007CHONGQING DAXIN PHARMACEUTICAL CO LTDMYCOPHENOLATE MOFETIL, NON-STERILE BULK DRUG SUBSTANCE
20948III10/15/2007EXCELLA GMBHMYCOPHENOLATE MOFETIL
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Moodys
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Novartis
Boehringer Ingelheim

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