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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 | 35498 | VILANTEROL TRIFENATATE | 2023-03-16 | Active | II | Complete | 2023-05-19 | 2023-01-09 |
28/03/2025 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 36450 | VILANTEROL TRIFENATATE | 2022-01-07 | Active | II | N/A |