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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/08/2025 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 15434 | ENALAPRIL MALEATE | 2001-05-15 | Active | II | N/A | ||
28/08/2025 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 19984 | ENALAPRIL MALEATE USP | 2006-11-17 | Active | II | Complete | 2016-06-28 | 2016-06-16 |