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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