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Last Updated: January 27, 2023

Drug Master Files for: regadenoson


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regadenoson Drug Master Files

DMF No. Status Type Submission Date Holder Subject
25939 A II 4/2/2012 FARMAK AS REGADENOSON MONOHYDRATE
27972 A II 2/12/2014 GLAND PHARMA LTD REGADENOSON
28939 A II 12/25/2014 SCINOPHARM TAIWAN LTD REGADENOSON
29185 A II 3/31/2015 WOCKHARDT BIO AG REGADENOSON (AMORPHOUS)
29315 A II 6/23/2015 USV PRIVATE LTD REGADENOSON MONOHYDRATE
30542 A II 5/10/2016 EUTICALS INC REGADENOSON
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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