Drug Master Files for: ETHANOLAMINE OLEATE
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ETHANOLAMINE OLEATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11311 | I | IV | 1/25/1995 | GENZYME PHARMACEUTICALS LLC | N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE SODIUM SALT (MPEG-DSPE) |
| 11553 | I | II | 6/12/1995 | AVANTI POLAR LIPIDS INC | 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE-N-(POLYETHYLENE GLYCOL 5000) |
| 13111 | I | II | 8/5/1998 | AVANTI POLAR LIPIDS INC | 1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE-N-GLUTARYL |
| 14925 | I | II | 6/18/2000 | AVANTI POLAR LIPIDS INC | 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE(DPPE) |
| 19731 | A | IV | 8/31/2006 | NOF CORP | N-(METHYLPOLYOXYETHYLENE OXYCARBONYL)-1, 2- DISTEAROYL--SN- GLYCERO-3- PHOSPHOETHANOLAMINE SODIUM SALT (DSPE-PEG2000) |
| 20221 | A | IV | 1/31/2007 | CORDEN PHARMA SWITZERLAND LLC | N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE SODIUM SALT (MPEG-2000-DSPE) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
