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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 | 34410 | TIOTROPIUM BROMIDE MONOHYDRATE (MICRONIZED AND NON-MICRONIZED) | 2020-03-17 | Active | II | Complete | 2021-04-30 | 2020-01-13 |
| 28/03/2025 | Vamsi Labs |
India |
VAMSI LABS LTD | 34808 | TIOTROPIUM BROMIDE MONOHYDRATE | 2020-04-15 | Active | II | Complete | 2021-01-11 | 2020-11-04 |
