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Last Updated: August 3, 2020

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Drug Master Files for: NITROGLYCERIN

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NITROGLYCERIN Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10058 A II 1/29/1993 COPPERHEAD INVESTMENTS INC SDM-71 NITROGLYCERIN TRANSDERMAL PATCH
10066 I II 2/1/1993 ZENECA INC SDM-70 NITROGLYCERIN/POLYMER MIXTURE
10110 A II 2/26/1993 COPPERHEAD INVESTMENTS INC SDM-74 (20/80 NITROGLYCERIN-SOLVATED ADHESIVE POLYMER)
1040 I II 3/7/1967 ATLAS CHEMICAL INDUSTRIES INC STANDARD DRUG MIXTURE NO. 16 (10% NITROGLYCERIN-LACTOSE MIXTURE)
10874 I V 4/13/1994 PHARMACO LIFE SCIENCE RESEARCH METHOD VALIDATION NITROGLYCERIN AND ITS DINITROGLYCERIN METABOLITES IN HUMAN PLASMA
11372 I V 3/9/1995 PHARMACO LIFE SCIENCE RESEARCH METHOD VALIDATION, GC/MS ANALYSIS OF TRINITROGLYCERIN, 1,2, DINITROGLYCERIN AND 1,3 DINITROGLYCERIN IN HUMAN PLASMA, METHOD MS42.1
11595 A II 7/21/1995 COPPERHEAD INVESTMENTS INC NITROGLYCERIN
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving leading biopharmaceutical companies globally:

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