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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
31/03/2026 Cohance Lifesciences
India
COHANCE LIFESCIENCES LTD 29211 ATOMOXETINE HYDROCHLORIDE USP 2015-03-26 Active II Complete 2019-12-27 2019-12-03
31/03/2026 Metrochem API Private Limited
India
METROCHEM API PRIVATE LTD 41086 VORTIOXETINE HYDROCHLORIDE 2024-12-31 Active II N/A