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Last Updated: February 20, 2020

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Drug Master Files for: thalidomide


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thalidomide Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15291 I II 2/19/2001 SIFAVITOR SPA THALIDOMIDE
18448 A II 6/23/2005 OLON SPA THALIDOMIDE
19745 A II 9/11/2006 HETERO LABS LTD THALIDOMIDE USP
21806 A II 7/28/2008 FIS FABBRICA ITALIANA SINTETICI SPA THALIDOMIDE
22678 I II 3/31/2009 DR REDDYS LABORATORIES LTD THALIDOMIDE
27967 A II 3/5/2014 LAURUS LABS LTD THALIDOMIDE USP
29452 A II 6/30/2015 MYLAN LABORATORIES LTD THALIDOMIDE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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