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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
28/10/2024 Cohance Lifesciences
India
COHANCE LIFESCIENCES LTD 22309 MECLIZINE HYDROCHLORIDE USP 2008-12-11 Active II Complete 2013-02-15 2013-01-18
28/10/2024 Calyx Chemicals & Pharmaceuticals Limited
India
CALYX CHEMICALS AND PHARMACEUTICALS LTD 29417 MECLIZINE HYDROCHLORIDE 2015-04-29 Active II N/A