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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 |