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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 34452 HYDRALAZINE HYDROCHLORIDE USP 2019-12-24 Active II Complete 2020-07-02 2020-03-05
28/03/2025 Alivus Life Sciences
India
GLENMARK LIFE SCIENCES LTD 35807 HYDRALAZINE HYDROCHLORIDE USP 2021-03-30 Active II Complete 2021-06-16 2021-06-02