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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 Cohance Lifesciences
India
COHANCE LIFESCIENCES LTD 29211 ATOMOXETINE HYDROCHLORIDE USP 2015-03-26 Active II Complete 2019-12-27 2019-12-03
28/03/2025 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 18440 ATOMOXETINE HYDROCHLORIDE USP 2005-06-22 Active II N/A