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Last Updated: November 2, 2024

Drug Master Files for: CHLOROQUINE PHOSPHATE


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CHLOROQUINE PHOSPHATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10472 I II 9/10/1993 ICN HUNGARY CO LTD CHLOROQUINE PHOSPHATE
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 PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD HYDROXYCHLOROQUINE SULFATE
21115 I II 2/6/2008 WUHAN WUYAO PHARMACEUTICAL CO LTD HYDROXYCHLOROQUINE SULFATE USP, NON-STERILE, BULK DRUG
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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