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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 | Medichem S.A |
Spain |
MEDICHEM MANUFACTURING (MALTA) LTD | 37978 | LOFEXIDINE HYDROCHLORIDE | 2023-07-17 | Active | II | Complete | 2023-08-15 | 2023-07-17 |
28/03/2025 | MSN Laboratories |
India |
MSN LABORATORIES PRIVATE LTD | 34636 | LOFEXIDINE HYDROCHLORIDE | 2020-02-28 | Active | II | Complete | 2023-01-30 | 2023-01-23 |