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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | EUROAPI |
France |
FRANCOPIA A EUROAPI CO | 21144 | NALBUPHINE HYDROCHLORIDE | 2007-06-20 | Active | II | Complete | 2014-06-23 | 2013-11-15 |
| 31/10/2025 | Mallinckrodt Pharmaceuticals |
Ireland |
SPECGX LLC | 11421 | NALBUPHINE HYDROCHLORIDE (LOW BETA EPIMER) CODE 3310 | 1995-03-31 | Active | II | N/A |
