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Last Updated: May 11, 2021

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Drug Master Files for: Lg Chem Ltd

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Lg Chem Ltd Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14524 A II 11/15/1999 LG CHEM LTD GEMIFLOXACIN MESYLATE
17416 A II 5/25/2004 LG CHEM LTD SODIUM HYALURONATE
19210 I III 3/2/2006 LG CHEM LTD ABS PRODUCTS INTENDED FOR USE IN DRUG PACKAGING APPLICATIONS
21292 I III 1/23/2008 LG CHEM LTD LDPE PRODUCTS INTENDED FOR USE IN DRUG PACKAGING APPLICATIONS
23497 A III 1/22/2010 LG CHEM LTD PP PRODUCTS
23498 A III 1/22/2010 LG CHEM LTD LDPE PRODUCTS
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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