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Generated: September 19, 2019

DrugPatentWatch Database Preview

Drug Master Files for: enalapril

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enalapril Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10200 I III 4/19/1993 3M PHARMACEUTICALS METHOD MS23.1, GC/MS ANALYSIS OF ENALAPRIL AND ENALAPRILAT IN HUMAN URINe
11170 I II 10/28/1994 MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC ENALAPRIL MALEATE & DILTIAZEM ER TABLETS
11525 A II 5/19/1995 FARMHISPANIA SA ENALAPRIL MALEATE
11622 I V 7/20/1995 PHARMACO LIFE SCIENCE RESEARCH METHOD MS23.1, GC/MS ANALYSIS OF ENALAPRIL AND ENALAPRILAT IN HUMAN URINE
11623 I V 7/20/1995 PHARMACO LIFE SCIENCE RESEARCH METHOD MS23 REVISION 1 GC/MS ANALYSIS OF ENALAPRIL AND ENALAPRILAT IN HUMAN PLASMA
11656 I II 9/18/1995 MAPRIMED SA ENALAPRIL MALEATE
11866 A II 2/27/1996 ESTEVE QUIMICA SA ENALAPRIL MALEATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

US Army
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