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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/03/2025 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 18113 | CABERGOLINE | 2005-02-21 | Active | II | Complete | 2012-11-02 | 2012-11-13 |
28/03/2025 | ACS DOBFAR SPA |
Italy |
ANTIBIOTICOS SPA | 7533 | CABERGOLINE ACTIVE DRUG SUBSTANCE | 1988-05-23 | Inactive | II | N/A |