Drug Master Files for: ethanolamine oleate

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ethanolamine oleate Drug Master Files

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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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