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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 30/12/2024 | Apotex Pharmachem |
Canada |
APOTEX PHARMACHEM INC | 19796 | EPLERENONE MEK HEMISOLVATE (1:0.5) | 2006-09-25 | Inactive | II | N/A | ||
| 30/12/2024 | Aurisco Pharmaceutical |
China |
AURISCO PHARMACEUTICAL CO LTD | 27672 | EPLERENONE | 2013-12-25 | Active | II | Complete | 2015-10-30 | 2013-12-02 |
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