Drug Master Files for: icosapent ethyl
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icosapent ethyl Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 22077 | I | II | 10/9/2008 | CHEMPORT INC | EICOSAPENTAENOIC ACID, 90% ETHYL ESTER |
| 23911 | A | II | 7/7/2010 | PRONOVA BIOPHARMA NORGE AS | EICOSAPENTAENOIC ACID ETHYL ESTER (EPA-E) |
| 26271 | A | II | 8/1/2012 | CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD | ETHYL ICOSAPENTATE |
| 26892 | A | II | 2/26/2013 | KD PHARMA BEXBACH GMBH | EICOSAPENTAENOIC ACID ETHYL ESTER |
| 27182 | A | II | 5/23/2013 | FINORGA SAS | ICOSAPENT ETHYL |
| 27998 | A | II | 2/10/2014 | AK AND MN BIOFARM CO LTD | AK & MN BIOFARM ICOSAPENTATE |
| 28422 | I | II | 6/13/2014 | SKUNY BIOSCIENCE CO LTD | ICOSAPENT ETHYL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
