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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | Interquim SA |
Spain |
INTERQUIM SA | 28471 | ROFLUMILAST | 2014-07-31 | Active | II | Complete | 2015-01-05 | 2014-07-23 |
| 29/11/2025 | Veranova |
U.S.A |
VERANOVA LP | 32093 | ROFLUMILAST | 2017-10-31 | Active | II | Complete | 2018-02-28 | 2017-09-25 |
