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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
29/11/2025 Kongo Chemical Co., Ltd.
Japan
KONGO CHEMICAL CO LTD 9844 CARBINOXAMINE MALEATE 1992-08-28 Active II Complete 2014-03-06 2014-03-04
29/11/2025 MSN Laboratories
India
MSN PHARMACHEM PRIVATE LTD 21301 CARBINOXAMINE MALEATE USP [ROUTE CODE - "CX"] 2008-01-31 Active II N/A