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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 25/04/2025 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 28026 | ESOMEPRAZOLE SODIUM | 2014-02-19 | Inactive | II | N/A | ||
| 25/04/2025 | PCAS |
France |
PCAS | 28375 | ESOMEPRAZOLE SODIUM | 2014-06-09 | Active | II | N/A |
