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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 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 36786 | IVOSIDENIB | 2022-02-17 | Active | II | Complete | 2022-05-11 | 2022-05-04 |
28/03/2025 | Teva Pharmaceutical Industries |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 36151 | IVOSIDENIB | 2022-02-04 | Active | II | Complete | 2022-03-02 | 2021-12-14 |