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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 Metrochem API Private Limited
India
METROCHEM API PRIVATE LTD 34731 LEVOCETIRIZINE DIHYDROCHLORIDE USP 2020-05-12 Active II N/A
28/10/2024 Cohance Lifesciences
India
COHANCE LIFESCIENCES LTD 21417 LEVOCETIRIZINE DIHYDROCHLORIDE USP 2008-03-11 Active II Complete 2013-08-17 2013-08-07