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List of Drug Master Files (DMF) of Hydroxyzine Hydrochloride Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 153Xls download

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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