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 | Polpharma |
Poland |
ZAKLADY FARMACEUTYCZNE POLPHARMA SA | 16962 | SODIUM ALENDRONATE | 2003-11-17 | Active | II | Complete | 2014-12-16 | 2014-11-28 |
28/10/2024 | Apotex Inc |
Canada |
APOTEX PHARMACHEM INC | 15409 | ALENDRONATE SODIUM TRIHYDRATE USP | 2001-04-30 | Active | II | N/A |
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