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Last Updated: April 18, 2024

Drug Master Files for: dipyridamole


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dipyridamole Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13870 A II 11/27/1998 MALGRAT PHARMA CHEMICALS SLU DIPYRIDAMOLE
14886 I II 5/16/2000 OMNICHEM NV DIPYRIDAMOLE USP
20416 A II 4/6/2007 ORCHID PHARMA LTD DIPYRIDAMOLE
22764 I II 5/8/2009 BOEHRINGER INGELHEIM LABSO CHIMIE FINE DIPYRIDAMOLE
23734 I II 4/14/2010 HAINAN POLY PHARMACEUTICAL CO LTD ASPIRIN AND DIPYRIDAMOLE EXTENDED RELEASE PELLETS CAPSULES
24441 A II 12/13/2010 MYLAN LABORATORIES LTD DIPYRIDAMOLE USP
28566 I II 8/14/2014 YABAO PHARMACEUTICAL GROUP CO LTD DIPYRIDAMOLE USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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