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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
28/11/2024 Hetero Drugs
India
HETERO LABS LTD 37216 DORAVIRINE PREMIX 2022-06-23 Active II Complete 2022-08-09 2022-06-17
28/11/2024 Viatris
U.S.A
TIANISH LABORATORIES PRIVATE LTD 38795 DORAVIRINE 2023-10-06 Active II N/A