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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | FARMAK, a.s |
Czech Republic |
FARMAK AS | 38922 | BROENAC SODIUM | 2023-10-18 | Active | II | N/A | ||
| 31/10/2025 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 24521 | BROENAC SODIUM (SESQUIHYDRATE) | 2011-05-20 | Active | II | Complete | 2013-10-17 | 2013-07-09 |

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