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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 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 24506 | LINEZOLID USP (FORM-II) | 2010-12-29 | Active | II | Complete | 2014-06-27 | 2014-06-23 |
28/03/2025 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 19032 | LINEZOLID | 2005-12-15 | Active | II | Complete | 2012-11-23 | 2012-11-09 |