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Last Updated: January 25, 2020

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Drug Master Files for: temozolomide

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temozolomide Drug Master Files

DMF No. Status Type Submission Date Holder Subject
19347 A II 4/10/2006 WAVELENGTH ENTERPRISES LTD TEMOZOLOMIDE
21669 A II 5/25/2008 JIANGSU TASLY DIYI PHARMACEUTICAL CO LTD TEMOZOLOMIDE (BULK, NON-STERILE A PHARMACEUTICAL INGREDIENT)
22775 A II 5/12/2009 RELIANCE LIFE SCIENCES PVT LTD TEMOZOLOMIDE USP
23158 A II 10/6/2009 FORMOSA LABORATORIES INC TEMOZOLOMIDE
23479 A II 1/22/2010 SHILPA MEDICARE LTD TEMOZOLOMIDE USP
23547 A II 2/17/2010 CHEMWERTH INC TEMOZOLOMIDE (NON-STERILE BULK DRUG SUBSTANCE)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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