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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 | 36482 | UMECLIDINIUM BROMIDE | 2023-06-16 | Active | II | Complete | 2023-07-12 | 2023-01-09 |
| 28/03/2025 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 32945 | UMECLIDINIUM BROMIDE | 2018-08-12 | Active | II | Complete | 2020-11-12 | 2020-09-08 |
