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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 | 38558 | OLODATEROL HYDROCHLORIDE | 2023-07-21 | Active | II | Complete | 2023-08-23 | 2023-07-12 |
| 28/03/2025 | Breathgreen Pharmaceuticals |
U.S.A |
BREATHGREEN PHARMACEUTICAL CO LTD | 38916 | OLODATEROL HYDROCHLORIDE | 2023-09-22 | Active | II | N/A |
