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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 24/02/2025 | Angelini Pharma |
Italy |
ANGELINI ACRAF SPA | 21348 | ACAMPROSATE CALCIUM | 2008-02-20 | Active | II | N/A | ||
| 24/02/2025 | Emcure Pharmaceuticals |
India |
EMCURE PHARMACEUTICALS LTD | 25809 | ACAMPROSATE CALCIUM USP | 2012-03-30 | Active | II | Complete | 2014-05-29 | 2014-01-22 |
