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Last Updated: November 22, 2024

Drug Master Files for: AZATHIOPRINE


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AZATHIOPRINE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10119 A II 2/19/1993 FINE CHEMICALS CORP PTY LTD AZATHIOPRINE
12589 I II 7/11/1997 FERMION OY AZATHIOPRINE
16806 I II 9/2/2003 ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD AZATHIOPRINE USP
17598 A II 8/12/2004 RESOLUTION CHEMICALS LTD AZATHIOPRINE USP
18739 I II 9/9/2005 PROMETHEUS LABORATORIES INC AZATHIOPRINE 50 MG TABLETS AND PLACEBO TABLETS
19669 I II 8/6/2006 ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD AZATHIOPRINE USP, NON-STERILE A PHARMACEUTICAL INGREDIENT
21674 I II 6/4/2008 RPG LIFE SCIENCES LTD AZATHIOPRINE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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