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Generated: November 19, 2018

DrugPatentWatch Database Preview

Drug Master Files for: hydroxychloroquine

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hydroxychloroquine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12762 I II 11/12/1997 ALKALOIDA CHEMICAL CO LTD HYDROXYCHLOROQUINE SULFATE
14087 A II 4/17/1999 IPCA LABORATORIES LTD HYDROXYCHLOROQUINE SULFATE USP
14977 A II 8/1/2000 CADILA HEALTHCARE LTD HYDROXYCHLOROQUINE SULFATE USP
20692 A II 7/17/2007 CHINOIN PHARMACEUTCIAL AND CHEMICAL WORKS CO LTD HYDROXYCHLOROQUINE SULFATE
21115 I II 2/6/2008 WUHAN WUYAO PHARMACEUTICAL CO LTD HYDROXYCHLOROQUINE SULFATE USP, NON-STERILE, BULK DRUG
21567 A II 4/25/2008 AMRI RENSSELAER INC HYDROXYCHLOROQUINE SULFATE, USP DRUG SUBSTANCE
23582 A II 3/25/2010 ALKALOIDA CHEMICAL CO ZRT HYDROXYCHLOROQUINE SULFATE USP
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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