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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
24/02/2025 | Alkem Laboratories |
India |
ALKEM LABORATORIES LTD | 33372 | ELUXADOLINE | 2019-01-02 | Active | II | Complete | 2019-03-01 | 2018-12-21 |
24/02/2025 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 33590 | ELUXADOLINE | 2019-02-16 | Active | II | Complete | 2019-03-13 | 2019-02-15 |