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 | EUROAPI |
France |
FRANCOPIA A EUROAPI CO | 21144 | NALBUPHINE HYDROCHLORIDE | 2007-06-20 | Active | II | Complete | 2014-06-23 | 2013-11-15 |
| 28/10/2024 | Mallinckrodt Pharmaceuticals |
Ireland |
SPECGX LLC | 23604 | NALBUPHINE HYDROCHLORIDE (1P) | 2010-04-29 | Active | II | Complete | 2015-02-23 | 2013-12-24 |
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