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Last Updated: February 28, 2021

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Drug Master Files for: atovaquone

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atovaquone Drug Master Files

DMF No. Status Type Submission Date Holder Subject
20672 I II 7/6/2007 USV LTD ATOVAQUONE USP
20908 A II 10/3/2007 CADILA HEALTHCARE LTD ATOVAQUONE USP
21001 I II 10/1/2007 ZHEJIANG HISOAR PHARMACEUTICAL CO LTD Atovaquone
21360 A II 2/15/2008 ROLABO OUTSOURCING SL ATOVAQUONE USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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