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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/06/2025 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 38789 | LACOSAMIDE USP | 2023-09-28 | Active | II | N/A | ||
28/06/2025 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 26381 | LACOSAMIDE | 2012-09-27 | Active | II | Complete | 2013-03-14 | 2012-10-25 |