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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 | 34411 | INDACATEROL MALEATE (MICRONIZED AND NON-MICRONIZED) | 2024-06-25 | Active | II | Complete | 2025-01-29 | 2024-12-09 |
| 28/03/2025 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 34294 | INDACATEROL MALEATE | 2019-12-31 | Active | II | N/A |
