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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 | 33409 | OSIMERTINIB MESYLATE | 2018-12-31 | Active | II | Complete | 2019-02-26 | 2018-12-12 |
| 28/03/2025 | Hetero Drugs |
India |
HETERO LABS LTD | 35581 | OSIMERTINIB MESYLATE | 2021-02-04 | Active | II | N/A |
