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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
04/06/2025 Dishman Carbogen Amcis
India
DISHMAN CARBOGEN AMCIS LTD 23075 OCTENIDINE HYDROCHLORIDE 2009-08-20 Inactive II N/A
04/06/2025 RN LABORATORIES EUROPE BV
Gabon
RN LABORATORIES EUROPE BV 34319 N-octyl-1-[10-(4-octyliminopyridin-1-yl) decyl] pyridin-4-imine dihydrochloride (Octenidine Dihydrochloride) 2019-12-11 Active II N/A