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| Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/03/2025 | Polpharma |
Poland |
ZAKLADY FARMACEUTYCZNE POLPHARMA SA | 20384 | SODIUM RISEDRONATE HEMI-PENTAHYDRATE | 2007-03-26 | Active | II | Complete | 2013-08-13 | 2012-12-11 |
| 28/03/2025 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 16604 | RISEDRONATE SODIUM | 2003-05-22 | Active | II | N/A |
