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Generated: December 16, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Sandoz Inc

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Sandoz Inc Drug Master Files

DMF No. Status Type Submission Date Holder Subject
4985 I II 4/22/1983 SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC GUANFACINE HYDROCHLORIDE
5191 I V 9/8/1983 SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC DATA FOR THE PHARMACOLOGY,TOXICOLOGY AND METABOLISM OF SOLULAN C-24
5610 I II 12/3/1984 SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC BUTALBITAL
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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