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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 | Moehs Iberica |
Spain |
MOEHS IBERICA SL | 22228 | BUPIVACAINE HYDROCHLORIDE | 2008-11-24 | Active | II | Complete | 2013-01-29 | 2013-01-07 |
28/03/2025 | Cambrex Corporation |
U.S.A |
CAMBREX KARLSKOGA AB | 5984 | BUPIVACAINE HYDROCHLORIDE | 1985-08-27 | Active | II | Complete | 2019-10-18 | 2019-10-15 |