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Last Updated: December 22, 2024

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Drug Master Files for: polyethylene glycol 3350


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polyethylene glycol 3350 Drug Master Files

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
10412 A III 8/16/1993 WESTLAKE POLYMERS CORP LOW DENSITY POLYETHYLENE (LDPE) RESINS
10487 I III 9/20/1993 AMPACET CORP 180132 SKIN TONE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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