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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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