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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 | Medichem S.A |
Spain |
MEDICHEM MANUFACTURING MALTA LTD | 28781 | AMBRISENTAN (MED-200028/M) | 2014-11-18 | Active | II | Complete | 2014-12-18 | 2014-11-19 |
28/10/2024 | Actavis Inc |
Ireland |
WATSON PHARMA PRIVATE LTD | 25134 | AMBRISENTAN | 2011-09-09 | Inactive | II | N/A |
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