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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 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 26241 | FESOTERODINE FUMARATE | 2012-09-04 | Active | II | Complete | 2013-05-06 | 2012-11-02 |
28/03/2025 | Apotex Pharmachem |
Canada |
SIGNA SA DE CV | 26345 | FESOTERODINE FUMARATE | 2012-08-17 | Active | II | Complete | 2013-04-23 | 2012-11-23 |