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Last Updated: November 2, 2024

Drug Master Files for: ISOSORBIDE DINITRATE


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ISOSORBIDE DINITRATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1021 I II 1/12/1967 NYSCO LABS INC ISOSORBIDE DINITRATE TIMED RELEASE PELLETS
10823 I II 3/18/1994 DOTTIKON EXCLUSIVE SYNTHESIS AG ISOSORBIDE-5-NITRATE EXTENDED RELEASE PREMIXTURE 49.2%
12564 I II 6/25/1997 SELOC AG ISOSORBIDE CONCENTRATE
12679 I II 10/2/1997 CAMBREX KARLSKOGA AB ISOSORBIDE-5-MONONITRATE/LACTOSE
1429 I II 3/3/1969 VICTOR M HERMELIN CO DIV K-V PHARMACAL CO ISORDIL TEMBIDS (ISOSORBIDE DINITRATE) SRC
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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