Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.
| Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/10/2024 | Inke S.A |
Spain |
INKE SA | 34411 | INDACATEROL MALEATE (MICRONIZED AND NON-MICRONIZED) | 2024-06-25 | Active | II | N/A | ||
| 28/10/2024 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 34294 | INDACATEROL MALEATE | 2019-12-31 | Active | II | N/A |
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