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Last Updated: June 25, 2022

Drug Master Files for: Glaxosmithkline Llc


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Glaxosmithkline Llc Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10729 A V 2/23/1994 GLAXOSMITHKLINE LLC PHARMACOLOGY AND TOXICOLOGY INFORMATION REGARDING PROPELLANT HFA-134A (GR106642X)
13207 A II 4/30/1998 GLAXOSMITHKLINE LLC AMOXICILLIN TRIHYDRATE
13338 I II 9/1/1998 GLAXOSMITHKLINE LLC GRISEOFULVIN
13961 I II 1/29/1999 GLAXOSMITHKLINE LLC MUPIROCIN FREE ACID AND MUPIROCIN CALCIUM (NON-STERILE)
15495 I II 6/7/2001 GLAXOSMITHKLINE LLC TICARCILLIN MONOSODIUM (NON-STERILE)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
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Baxter
Merck
Dow

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