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Last Updated: November 14, 2019

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Drug Master Files for: alvimopan

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alvimopan Drug Master Files

DMF No. Status Type Submission Date Holder Subject
24035 I II 7/26/2010 ALP PHARM BEIJING CO LTD ALVIMOPAN DIHYDRATE
25908 I II 4/2/2012 ALP PHARM BEIJING CO LTD ALVIMOPAN DIHYDRATE
30553 A II 5/24/2016 TEVA PHARMACEUTICAL INDUSTRIES LTD ALVIMOPAN DIHYDRATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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