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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 | Inke S.A |
Spain |
INKE SA | 36437 | ACLIDINIUM BROMIDE | 2023-03-16 | Active | II | Complete | 2023-06-14 | 2023-04-21 |
28/03/2025 | Almirall |
Spain |
RANKE QUIMICA SA | 16926 | LAS 34273 | 2003-10-17 | Active | II | N/A |