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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 | Inke S.A |
Spain |
INKE SA | 31836 | GLYCOPYRROLATE | 2017-07-22 | Active | II | Complete | 2018-02-16 | 2017-07-06 |
28/03/2025 | Seqens |
France |
PCAS | 18106 | GLYCOPYRROLATE | 2005-02-22 | Active | II | Complete | 2013-10-05 | 2013-09-30 |