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Last Updated: February 24, 2021

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Drug Master Files for: iloperidone

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iloperidone Drug Master Files

DMF No. Status Type Submission Date Holder Subject
24481 A II 12/22/2010 FORMOSA LABORATORIES INC ILOPERIDONE
24832 A II 4/6/2011 ALEMBIC PHARMACEUTICALS LTD ILOPERIDONE
24932 A II 5/10/2011 SYMED LABS LTD ILOPERIDONE
25577 A II 11/28/2011 MYLAN LABORATORIES LTD ILOPERIDONE
26945 A II 3/4/2013 PROCOS SPA ILOPERIDONE
27039 A II 5/16/2013 MSN ORGANICS PRIVATE LTD ILOPERIDONE [ROUTE CODE - IO]
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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