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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 34668 | MEXILETINE HYDROCHLORIDE | 2020-03-06 | Active | II | Complete | 2020-09-01 | 2020-08-06 |
28/10/2024 | Cohance Lifesciences |
India |
COHANCE LIFESCIENCES LTD | 34958 | MEXILETINE HYDROCHLORIDE USP | 2020-06-19 | Active | II | Complete | 2021-05-12 | 2021-03-24 |
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