Drug Master Files for: GLYCEROL PHENYLBUTYRATE

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GLYCEROL PHENYLBUTYRATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10402	I	II	8/4/1993	GANES CHEMICALS INC PENNSVILLE DIV	IODINATED GLYCEROL AZEO
10403	I	II	8/4/1993	GANES CHEMICALS INC PENNSVILLE DIV	IODINATED GLYCEROL SOLUTION
10404	I	II	8/4/1993	GANES CHEMICALS INC PENNSVILLE DIV	IODINATED GLYCEROL CONCENTRATE
10923	I	II	5/25/1994	GENZYME CORP	SN-1-PALMITOYL-2-OLEOYLPHOSPHATIDYLGLYCEROL SODIUM SALT (POPG.NA)
11463	A	II	4/12/1995	NOF CORP	DIMYRISTOYL PHOSPHATIDYL GLYCEROL AMMONIUM/SODIUM SALT
12233	A	IV	11/22/1996	CORDEN PHARMA SWITZERLAND LLC	1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOGLYCEROL, SODIUM SALT (DSPG, NA)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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