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Generated: June 24, 2019

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Drug Master Files for: cytarabine; daunorubicin

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cytarabine; daunorubicin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1534 I II 6/1/1970 PHARMACIA AND UPJOHN CYTARABINE
15959 A II 4/28/2002 ZHEJIANG HISUN PHARMACEUTICAL CO LTD CYTARABINE USP
16896 A II 10/6/2003 PFANSTIEHL INC CYTARABINE USP
18071 I II 1/21/2005 AXITEC CO LTD CYTARABINE, USP
23469 I II 1/12/2010 CHANGZHOU AHK TECH INC CYTARABINE USP NON-STERILE BULK DRUG
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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