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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
25/04/2025 | Guilin Pharmaceutical Ltd |
China |
GUILIN PHARMACEUTICAL CO LTD | 8682 | BUMETANIDE USP | 1990-07-31 | Active | II | Complete | 2014-03-07 | 2013-07-15 |
26/04/2025 | Hainan Poly Pharm |
China |
HAINAN POLY PHARM CO LTD | 40272 | BUMETANIDE USP | 2024-07-31 | Active | II | N/A |