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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 27/09/2025 | Moehs Iberica |
Spain |
MOEHS IBERICA SL | 32818 | PRILOCAINE | 2018-06-29 | Active | II | Complete | 2018-09-28 | 2018-08-01 |
| 27/09/2025 | Apex Healthcare Limited |
India |
APEX HEALTHCARE LTD | 41905 | PRILOCAINE USP | 2025-06-04 | Active | II | N/A |
