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Last Updated: November 17, 2019

DrugPatentWatch Database Preview

Drug Master Files for: bortezomib

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bortezomib Drug Master Files

DMF No. Status Type Submission Date Holder Subject
22160 A II 10/31/2008 TEVA PHARMACEUTICAL INDUSTRIES LTD BORTEZOMIB
22884 I II 6/19/2009 VIWIT PHARMACEUTICAL CO LTD BORTEZOMIB
22922 A II 6/30/2009 APICORE US LLC BORTEZOMIB
23996 A II 7/26/2010 DR REDDYS LABORATORIES LTD BORTEZOMIB
24944 A II 8/23/2011 SHILPA MEDICARE LTD BORTEZOMIB
25482 I II 11/8/2011 HETERO LABS LTD BORTEZOMIB (FORM-II)
25665 A II 12/30/2011 SCINOPHARM TAIWAN LTD BORTEZOMIB
>DMF No. >Status >Type >Submission Date >Holder >Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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