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 | Noramco |
U.S.A |
NORAMCO LLC | 21084 | TAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE | 2008-01-23 | Active | II | Complete | 2020-08-05 | 2020-07-30 |
| 28/10/2024 | Alkem Laboratories |
India |
ALKEM LABORATORIES LTD | 26519 | TAPENTADOL HYDROCHLORIDE | 2012-10-23 | Active | II | Complete | 2013-03-01 | 2012-11-08 |
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