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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
29/07/2025 | FARMAK, a.s |
Czech Republic |
FARMAK AS | 15585 | BRIMONIDINE TARTRATE | 2001-08-15 | Active | II | Complete | 2012-10-26 | 2012-12-19 |
29/07/2025 | Maithri Drugs |
India |
MAITHRI DRUGS PRIVATE LTD | 36595 | BRIMONIDINE TARTRATE USP | 2021-12-09 | Active | II | N/A |