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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
28/03/2025 Neuland Laboratories
India
NEULAND LABORATORIES LTD 26347 DAPIPRAZOLE HYDROCHLORIDE 2012-08-23 Active II Complete 2014-01-14 2013-09-25
28/03/2025 Angelini Pharma
Italy
ANGELINI ACRAF SPA 4334 DAPIPRAZOLE HYDROCHLORIDE 1981-10-28 Active II N/A