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

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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 Chemi SpA
Italy
CHEMI SPA 4629 HYDROXYZINE PAMOATE USP. XX 1982-08-11 Inactive II N/A
26/09/2024 COSMA S.p.A
Italy
COSMA SPA 4514 HYDROXYZINE PAMOATE 1982-04-16 Active II Complete 2013-09-28 2013-09-24