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Last Updated: December 22, 2024

Drug Master Files for: MERCAPTOPURINE


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MERCAPTOPURINE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15249 A II 1/15/2001 FERMION OY 6-MERCAPTOPURINE
16575 I II 4/30/2003 CHANGZHOU SIYAO PHARMACEUTICALS CO LTD MERCAPTOPURINE USP
16805 I II 9/2/2003 ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD MERCAPTOPURINE USP
19668 I II 8/6/2006 ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD MERCAPTOPURINE, USP, NON-STERILE A PHARMACEUTICAL INGREDIENT
21267 I II 1/22/2008 BENZOCHEM LIFESCIENCES PVT LTD MERCAPTOPURINE USP
21758 I II 7/1/2008 RPG LIFE SCIENCES LTD MERCAPTOPURINE USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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