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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
24/02/2025 | ACS DOBFAR SPA |
Italy |
ANTIBIOTICOS SA | 13549 | AMOXICILLIN | 1998-09-01 | Active | II | N/A | ||
24/02/2025 | ADL BioPharma |
Spain |
ANTIBIOTICOS DE LEON SLU | 30725 | AMOXICILLIN TRIHYDRATE | 2016-07-06 | Active | II | Complete | 2017-08-02 | 2016-10-14 |