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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
29/01/2026 Maithri Drugs
India
MAITHRI DRUGS PRIVATE LTD 34632 DAPOXETINE HYDROCHLORIDE 2020-02-28 Active II N/A
29/01/2026 Johnson & Johnson Innovative Medicine
U.S.A
JANSSEN PHARMACEUTICA NV 17828 DAPOXETINE HYDROCHLORIDE 2004-12-15 Inactive II N/A