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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 | Bachem AG |
Switzerland |
BACHEM AMERICAS INC | 17227 | EXENATIDE (BULK) | 2004-03-05 | Active | II | Complete | 2014-03-21 | 2013-09-16 |
28/03/2025 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 27123 | EXENATIDE | 2013-07-07 | Active | II | Complete | 2013-08-19 | 2013-05-09 |