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Generated: September 22, 2019

DrugPatentWatch Database Preview

Drug Master Files for: cabazitaxel

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cabazitaxel Drug Master Files

DMF No. Status Type Submission Date Holder Subject
23496 A II 1/29/2010 SANOFI CHIMIE CABAZITAXEL ACETONE SOLVATE
25769 A II 2/7/2012 POLYMED THERAPEUTICS INC CABAZITAXEL MONOHYDRATE DRUG SUBSTANCE
26462 I II 9/18/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD CABAZITAXEL
27339 A II 7/18/2013 POLYMED THERAPEUTICS INC CABAZITAXEL ETHYL ACETATE SOLVATE DRUG SUBSTANCE
27441 A II 9/26/2013 QILU PHARMACEUTICAL CO LTD CABAZITAXEL
27831 A II 3/3/2014 MSN LABORATORIES PRIVATE LTD CABAZITAXEL [ROUTE CODE CZ]
27895 A II 2/18/2014 DR REDDYS LABORATORIES LTD CABAZITAXEL
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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