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Last Updated: March 2, 2021

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Drug Master Files for: dolutegravir

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dolutegravir Drug Master Files

DMF No. Status Type Submission Date Holder Subject
28721 A II 10/14/2014 AUROBINDO PHARMA LTD DOLUTEGRAVIR SODIUM
30011 A II 11/26/2015 MYLAN LABORATORIES LTD DOLUTEGRAVIR SODIUM
30055 A II 3/17/2016 CIPLA LTD DOLUTEGRAVIR SODIUM
30365 A II 2/3/2016 SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD DOLUTEGRAVIR SODIUM
30544 A II 5/20/2016 HETERO LABS LTD DOLUTEGRAVIR SODIUM
30933 A II 12/19/2016 LEK PHARMACEUTICALS DD DOLUTEGRAVIR SODIUM
30935 A II 9/28/2016 LAURUS LABS LTD DOLUTEGRAVIR SODIUM
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

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McKesson
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Moodys

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