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Last Updated: October 1, 2020

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Drug Master Files for: asenapine maleate

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asenapine maleate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
25745 A II 3/26/2012 DR REDDYS LABORATORIES LTD ASENAPINE MALEATE
26104 A II 5/30/2012 OLON SPA ASENAPINE MALEATE
26785 A II 3/8/2013 MSN ORGANICS PRIVATE LTD ASENAPINE MALEATE [ROUTE CODE AN]
26973 A II 3/23/2013 MSN ORGANICS PRIVATE LTD ASENAPINE MALEATE [ROUTE CODE AOI]
27086 A II 5/17/2013 MYLAN LABORATORIES LTD ASENAPINE MALEATE
27185 A II 7/17/2013 SUN PHARMACEUTICAL INDUSTRIES LTD ASENAPINE MALEATE
27194 A II 7/4/2013 ALEMBIC PHARMACEUTICALS LTD ASENAPINE MALEATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Baxter
Moodys
Mallinckrodt
Colorcon
Boehringer Ingelheim
Harvard Business School

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