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Generated: November 14, 2018

DrugPatentWatch Database Preview

Drug Master Files for: mannitol

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mannitol Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12879 A II 2/26/1998 ROQUETTE FRERES MANNITOL USP GRADE (PEARLITOL PF)
14891 A IV 5/16/2000 ROQUETTE FRERES MANNITOL, SPRAY DRIED
16362 I IV 1/16/2003 SPI PHARMA INC MANNOGEM(TM) EZ SPRAY DRIED MANNITOL USP
171 I II 8/16/1955 NEW DRUG INSTITUTE RAUWOLFIA SERPERTINA WHOLE ROOT,MANNITOL HEXANITRATE ,
18143 A IV 3/8/2005 ROQUETTE FRERES MANNITOL USP POWDER PEARLITOL ?
21783 A IV 6/25/2008 DUPONT NUTRITION USA INC AVICEL HFE MICROCRYSTALLINE CELLULOSE AND MANNITOL
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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