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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 | Moehs Iberica |
Spain |
MOEHS IBERICA SL | 13992 | SOTALOL HCI | 1999-02-22 | Active | II | Complete | 2021-06-22 | 2021-06-16 |
| 28/03/2025 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 14951 | SOTALOL HYDROCHLORIDE USP | 2000-07-13 | Active | II | Complete | 2014-06-27 | 2014-06-23 |
