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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
25/04/2025 | Centrient Pharmaceuticals |
Netherlands |
CENTRIENT PHARMACEUTICALS NETHERLANDS BV | 13749 | CEFADROXIL MONOHYDRATE USP (PURIDROX ®) | 1998-09-01 | Active | II | Complete | 2014-01-22 | 2013-01-11 |
25/04/2025 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 17509 | CEFADROXIL | 2004-07-01 | Active | II | N/A |