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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/03/2025 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 26347 | DAPIPRAZOLE HYDROCHLORIDE | 2012-08-23 | Active | II | Complete | 2014-01-14 | 2013-09-25 |
28/03/2025 | Angelini Pharma |
Italy |
ANGELINI ACRAF SPA | 4334 | DAPIPRAZOLE HYDROCHLORIDE | 1981-10-28 | Active | II | N/A |