Drug Master Files for: OMEGA-3-ACID ETHYL ESTERS
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OMEGA-3-ACID ETHYL ESTERS Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14685 | A | II | 1/26/2000 | CATALENT PHARMA SOLUTIONS LLC | LOVAZA 1 G SOFT GELATIN CAPSULES(OMEGA-3-ACID ETHYL ESTERS, 1 GRAM) |
| 22106 | A | II | 10/17/2008 | CRODA EUROPE LTD | OMEGA-3-ACID ETHYL ESTERS |
| 22284 | I | II | 11/3/2008 | OLON SPA | OMEGA-3-ACID ETHYL ESTERS |
| 22285 | A | II | 10/17/2008 | HUATAI BIOPHARM INC | OMEGA-3-ACID ETHYL ESTERS USP |
| 23905 | I | II | 7/12/2010 | KD PHARMA BEXBACH GMBH | OMEGA-3-ACIDS ETHYL ESTER |
| 25342 | A | II | 9/7/2011 | CHEMPORT INC | OMEGA-3-ACID ETHYL ESTERS |
| 26056 | A | II | 8/31/2012 | PRONOVA BIOPHARMA NORGE AS | OMEGA-3-ACID ETHYL ESTERS |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
