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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 | Cambrex Corporation |
U.S.A |
CAMBREX KARLSKOGA AB | 19177 | BUPIVACAINE BASE | 2006-02-10 | Active | II | Complete | 2015-10-05 | 2015-09-29 |
28/03/2025 | Dishman Carbogen Amcis |
India |
DISHMAN CARBOGEN AMCIS LTD | 32369 | BUPIVACAINE | 2017-12-22 | Active | II | Complete | 2018-04-13 | 2018-03-09 |