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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

Drug Master Files for: Tris Pharma Inc

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Tris Pharma Inc Drug Master Files

DMF No. Status Type Submission Date Holder Subject
23870 A II 7/20/2010 TRIS PHARMA INC METHYLPHENIDATE ERL (METHYLPHENIDATE ER POWDER FOR ORAL SUSPENSION)
25909 A II 4/18/2012 TRIS PHARMA INC METHYLPHENIDATE ERCT (METHYLPHENIDATE HCI ER CHEWABLE TABLETS)
27314 A II 7/26/2013 TRIS PHARMA INC COD-CPM ER ORAL SUSPENSION
29361 A II 7/17/2015 TRIS PHARMA INC HCD-CPM-PSEUD ER OS (HYDROCODONE POLISTIREX, CHLORPHENIRAMINE POLISTIREX AND PSEUDOEPHEDRINE POLISTIREX ER ORAL SUSPENSION)
29687 A II 11/3/2015 TRIS PHARMA INC COD-CPM-PSE ER ORAL SUSPENSION
33094 A II 9/11/2018 TRIS PHARMA INC OXYBATE EXTENDED RELEASE POWDER FOR ORAL SUSPENSION (EQ. TO 4.5 G OF SODIUM OXYBATE) (Cl)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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