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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 | DOTTIKON EXCLUSIVE SYNTHESIS AG |
Switzerland |
DOTTIKON EXCLUSIVE SYNTHESIS AG | 10823 | ISOSORBIDE-5-NITRATE EXTENDED RELEASE PREMIXTURE 49.2% | 1994-03-18 | Inactive | II | N/A | ||
| 28/03/2025 | SELOC AG | 12564 | ISOSORBIDE CONCENTRATE | 1997-06-25 | Inactive | II | N/A |
