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Generated: September 19, 2019

DrugPatentWatch Database Preview

Drug Master Files for: cinacalcet

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cinacalcet Drug Master Files

DMF No. Status Type Submission Date Holder Subject
21264 A II 1/23/2008 TEVA PHARMACEUTICAL INDUSTRIES LTD CINACALCET HYDROCHLORIDE
21405 A II 3/6/2008 MEDICHEM MANUFACTURING MALTA LTD CINACALCET HYDROCHLORIDE (MED-200140/M )
23910 A II 6/23/2010 ACTAVIS GROUP PTC EHF CINACALCET HYDROCHLORIDE (NON-STERILE BULK DRUG SUBSTANCE)
24297 A II 10/29/2010 IND SWIFT LABORATORIES LTD CINACALCET HYDROCHLORIDE
24881 A II 4/22/2011 MEGAFINE PHARMA P LTD CINACALCET HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE)
25889 A II 3/29/2012 JUBILANT GENERICS LTD CINACALCET HYDROCHLORIDE
>DMF No. >Status >Type >Submission Date >Holder >Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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