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Last Updated: December 22, 2024

Drug Master Files for: INDAPAMIDE


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INDAPAMIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
21663 A II 5/20/2008 INDUSTRIALE CHIMICA SRL INDAPAMIDE
21975 A II 10/6/2008 IPCA LABORATORIES LTD INDAPAMIDE USP
22388 I II 1/6/2009 DISHMAN PHARMACEUTICALS AND CHEMICALS LTD INDAPAMIDE
8577 I II 5/21/1990 ORIL INDUSTRIE INDAPAMIDE
9026 A II 3/28/1991 BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPA INDAPAMIDE
9064 A II 3/25/1991 QUIMICA SINTETICA SA INDAPAMIDE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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