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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 | Quimica Sintetica |
Spain |
QUIMICA SINTETICA SA | 9440 | KETOTIFEN FUMERATE | 1991-11-11 | Inactive | II | N/A | ||
| 28/03/2025 | Sifavitor srl |
Italy |
OLON SPA | 16201 | KETOTIFEN HYDROGEN FUMARATE | 2002-10-14 | Active | II | Complete | 2015-02-22 | 2015-02-13 |
