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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
29/07/2025 Cosma
Italy
COSMA SPA 4435 HYDROXYZINE HYDROCHLORIDE 1982-01-29 Active II Complete 2014-05-15 2014-01-28
29/07/2025 Chemische Fabrik Berg
Germany
CHEMISCHE FABRIK BERG GMBH 35249 HYDROXYZINE HYDROCHLORIDE 2023-12-05 Active II Complete 2024-03-12 2023-12-01