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Last Updated: November 4, 2024

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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