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 | Axplora |
Germany |
PHARMAZELL GMBH | 8070 | 5-AMINOSALICYLIC ACID (MESALAZINE/MESALAMINE) | 1989-05-09 | Active | II | Complete | 2014-12-16 | 2014-11-28 |
| 28/10/2024 | Zhejiang Hengkang Pharmaceutical |
China |
ZHEJIANG HENGKANG PHARMACEUTICAL CO LTD | 37319 | MESALAMINE USP | 2022-08-17 | Active | II | Complete | 2022-10-20 | 2022-09-16 |
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