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List of Drug Master Files (DMF) of Dolutegravir And Rilpivirine Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
26/09/2024 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 28721 DOLUTEGRAVIR SODIUM 2014-10-14 Active II Complete 2015-01-08 2014-10-10
26/09/2024 Cipla
India
CIPLA LTD 31107 DOLUTEGRAVIR SODIUM (FORM C) 2017-02-11 Active II Complete 2017-03-01 2016-11-07