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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
26/09/2024 | Chemische Fabrik Berg |
Germany |
CHEMISCHE FABRIK BERG GMBH | 35249 | HYDROXYZINE HYDROCHLORIDE | 2023-12-05 | Active | II | Complete | 2024-03-12 | 2023-12-01 |
26/09/2024 | Calyx Chemicals & Pharmaceuticals Limited |
India |
CALYX CHEMICALS AND PHARMACEUTICALS LTD | 24002 | HYDROXYZINE HYDROCHLORIDE | 2010-07-22 | Active | II | N/A |
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