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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 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 30814 | CLOMIPRAMINE HYDROCHLORIDE | 2016-08-20 | Active | II | Complete | 2016-10-21 | 2016-08-22 |
24/02/2025 | H. Lundbeck AS |
Denmark |
LUNDBECK PHARMACEUTICALS ITALY SPA | 8864 | CLOMIPRAMINE HYDROCHLORIDE | 1990-11-19 | Active | II | Complete | 2015-02-25 | 2015-01-26 |