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Generated: November 21, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Santen

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Santen Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10927 I II 6/3/1994 SANTEN PHARMACEUTICAL CO LTD MANUFACTURING PLANT AT NOTO, JAPAN
14320 I II 7/29/1999 SANTEN PHARMACEUTICAL CO LTD CS-011 DRUG SUBSTANCE
16643 I V 6/12/2003 SANTEN OY STERILIZATION PROCESS FOR CONTINUOUS MOTION (CM1) COMPOUNDING AND FILLING LINE
3446 I II 2/6/1979 SANTEN PHARMACEUTICAL CO LTD THIOLA
5257 I II 5/11/1983 SANTEN PHARMACEUTICAL CO LTD TROPICAMIDE MYDRIATIC
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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