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Generated: April 24, 2019

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Drug Master Files for: mometasone

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mometasone Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14991 A II 5/26/2000 HOVIONE FARMACIENCIA SA MOMETASONE 17-FUROATE
15063 A II 9/29/2000 TEVA PHARMACEUTICAL INDUSTRIES LTD MOMETASONE FUROATE USP
15187 A II 12/7/2000 WAVELENGTH ENTERPRISES LTD MOMETASONE FUROATE
16648 A II 6/16/2003 STERLING SPA MOMETASONE FUROATE
19023 A III 12/9/2005 3M DRUG DELIVERY SYSTEMS DIV MOMETASONE & FORMOTEROL COMBINATION PRODUCT PMDI ACTUATOR
19781 I II 9/20/2006 SYMBIOTEC PHARMALAB PRIVATE LTD MOMETASONE FUROATE
20684 A II 7/12/2007 SYMBIOTEC PHARMALAB PRIVATE LTD MOMETASONE FUROATE USP (MICRONISED)
DMF No. Status Type Submission Date Holder Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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