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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 | EUROAPI |
France |
EUROAPI HUNGARY LTD | 19690 | IRBESARTAN DRUG SUBSTANCE | 2006-08-15 | Active | II | N/A | ||
28/03/2025 | Sanofi |
France |
SANOFI CHIMIE | 10310 | IRBESARTAN DRUG SUBSTANCE | 1993-06-30 | Active | II | N/A |