Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.
Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 30564 | LABETALOL HYDROCHLORIDE USP | 2016-06-07 | Active | II | Complete | 2017-01-31 | 2017-01-11 |
28/10/2024 | Cambrex Corporation |
U.S.A |
CAMBREX PROFARMACO MILANO SRL | 12758 | LABETALOL HYDROCHLORIDE | 1997-11-24 | Active | II | N/A |
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