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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
04/06/2025 | Alivus Life Sciences |
India |
ALIVUS LIFE SCIENCES LTD | 33296 | GABAPENTIN ENACARBIL | 2018-11-02 | Active | II | Complete | 2018-11-21 | 2018-11-02 |
04/06/2025 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 39197 | GABAPENTIN ENACARBIL | 2023-12-01 | Active | II | Complete | 2023-12-20 | 2023-11-29 |