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Last Updated: April 24, 2024

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Drug Master Files for: POLYETHYLENE GLYCOL 3350

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POLYETHYLENE GLYCOL 3350 Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10074	I	III	12/12/1992	STATOIL	STATOIL POLYETHYLENE LDPE, L610
10118	I	III	3/8/1993	AMCOR FLEXIBLES ITALIA SRL	PAPER / ALUMINUM / POLYETHYLENE LAMINATE DRUG WRAPPER PRODUCT WITH GLUE AND PAPER
10149	I	III	3/24/1993	SOLVAY AND CIE SA	HD POLYETHYLENE ELTEX A 4019
10318	A	III	6/29/1993	BAYPORT POLYMERS LLC	MANUFACTURE OF POLYETHYLENE
10367	I	III	7/16/1993	AMPACET CORP	10005 ANTISTAT POLYETHYLENE MASTERBATCH
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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