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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