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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | Moehs Iberica |
Spain |
MOEHS IBERICA SL | 6924 | AMANTADINE HYDROCHLORIDE | 1987-04-08 | Active | II | Complete | 2014-05-16 | 2014-05-13 |
| 31/10/2025 | Olpha |
Latvia |
OLPHA AS | 23528 | AMANTADINE HYDROCHLORIDE | 2010-02-11 | Active | II | Complete | 2013-11-20 | 2012-11-27 |
