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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 | 16628 | FORMOTEROL FUMARATE | 2003-06-03 | Active | II | Complete | 2017-06-16 | 2017-05-10 |
| 28/03/2025 | Coral Drugs Private Limited |
India |
CORAL DRUGS PRIVATE LTD | 30324 | FORMOTEROL FUMARATE DIHYDRATE | 2016-06-04 | Active | II | N/A |
