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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/11/2024 | Shenyang Hongqi Pharmaceutical |
China |
SHENYANG HONGQI PHARMACEUTICAL CO LTD | 38642 | PRETOMANID | 2023-09-28 | Active | II | Complete | 2024-01-08 | 2023-12-26 |
| 28/11/2024 | Viatris |
U.S.A |
TIANISH LABORATORIES PRIVATE LTD | 38796 | PRETOMANID | 2023-10-31 | Active | II | N/A |
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