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Last Updated: March 28, 2024

Drug Master Files for: formoterol fumarate


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formoterol fumarate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12380 I II 2/24/1997 ASTELLAS PHARMA INC FORMOTEROL FUMARATE
12426 I II 3/19/1997 YAMANOUCHI IRELAND CO LTD FORMOTEROL FUMERATE
14154 I II 5/25/1999 INDUSTRIALE CHIMICA SRL FORMOTEROL FUMARATE DIHYDRATE MICRONIZED
16241 I II 11/13/2002 SICOR SWISS BRANCH FORMOTEROL FUMARATE
16628 A II 6/3/2003 INKE SA FORMOTEROL FUMARATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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