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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 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 34756 | LURASIDONE HYDROCHLORIDE | 2020-07-14 | Active | II | N/A | ||
28/03/2025 | Veranova |
U.S.A |
VERANOVA LP | 34255 | LURASIDONE HCL | 2020-01-31 | Active | II | Complete | 2020-04-07 | 2019-12-03 |