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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/03/2025 | Hetero Drugs |
India |
HETERO LABS LTD | 37216 | DORAVIRINE PREMIX | 2022-06-23 | Active | II | Complete | 2022-08-09 | 2022-06-17 |
28/03/2025 | Viatris |
U.S.A |
TIANISH LABORATORIES PRIVATE LTD | 38795 | DORAVIRINE | 2023-10-06 | Active | II | N/A |