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Last Updated: December 12, 2019

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Drug Master Files for: CHLORHEXIDINE GLUCONATE

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CHLORHEXIDINE GLUCONATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11465 I II 4/19/1995 ARZNEIMITTELWERK DRESDEN GMBH CHLORHEXIDINE (BASE)
12492 I II 4/21/1997 THATCHER CO CHLORHEXIDINE GLUCONATE, 20% (W/V)
13124 I II 7/27/1998 JINZHOU JIUTAI PHARMACEUTICAL CO LTD CHLORHEXIDINE ACETATE
14250 I II 5/26/1999 ECOLAB INC 20% CHLORHEXIDINE GLUCONATE
16075 I II 7/25/2002 CADILA PHARMACEUTICALS LTD CHLORHEXIDINE BASE
16206 I II 10/15/2002 ROHIT PLASTICS AND CHEMICALS CHLORHEXIDINE GLUCONATE 20%
16253 I II 11/18/2002 R N PHARMACEUTICALS CHLORHEXIDINE ACETATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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