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Last Updated: December 25, 2024

Drug Master Files for: pemetrexed ditromethamine


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pemetrexed ditromethamine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
21180 A II 1/3/2008 TEVA PHARMACEUTICAL INDUSTRIES LTD PEMETREXED DIACID
22141 A II 11/3/2008 CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE CO LTD PEMETREXED DISODIUM, (NON-STERILE BULK DRUG SUBSTANCE)
23341 A II 11/28/2009 QILU PHARMACEUTICAL CO LTD PEMETREXED DISODIUM
23417 A II 12/28/2009 CHEMWERTH INC PEMETREXED DISODIUM NON-STERILE BULK DRUG SUBSTANCE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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