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Generated: April 23, 2019

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Drug Master Files for: daunorubicin

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daunorubicin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11879 A II 2/29/1996 MICROBIOPHARM JAPAN CO LTD DAUNORUBICIN HYDROCHLORIDE (CRUDE)
13503 I II 9/1/1998 RHONE POULENC RORER PHARMACEUTICALS INC DAUNORUBICIN HYDROCHLORIDE
13727 A II 9/1/1998 MEIJI SEIKA PHARMA CO LTD DAUNORUBICIN HYDROCHLORIDE (DRUG SUBSTANCE)
13775 A II 9/1/1998 ZHEJIANG HISUN PHARMACEUTICAL CO LTD DAUNORUBICIN HYDROCHLORIDE USP
13786 A II 9/1/1998 TEVA PHARMACEUTICAL INDUSTRIES LTD DAUNORUBICIN HYDROCHLORIDE
DMF No. Status Type Submission Date Holder Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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