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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | Dipharma |
Italy |
DIPHARMA FRANCIS SRL | 3725 | ISOSORBIDE DINITRATE (ISDN) | 1980-02-07 | Active | II | Complete | 2016-06-15 | 2016-02-25 |
28/10/2024 | DOTTIKON EXCLUSIVE SYNTHESIS AG |
Switzerland |
DOTTIKON EXCLUSIVE SYNTHESIS AG | 2663 | ISOSORBIDE DINITRATE, DILUTED | 1976-05-07 | Active | II | N/A |
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