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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | Cosma (C.F.M. Group) |
Italy |
COSMA SPA | 4514 | HYDROXYZINE PAMOATE | 1982-04-16 | Active | II | Complete | 2013-09-28 | 2013-09-24 |
| 31/10/2025 | Chemi SpA |
Italy |
CHEMI SPA | 4629 | HYDROXYZINE PAMOATE USP. XX | 1982-08-11 | Inactive | II | N/A |
