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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 | 5N Plus Lubeck GmbH |
Canada |
5N PLUS LUBECK GMBH | 30295 | BISMUTH SUBCITRATE POTASSIUM | 2017-09-06 | Active | II | Complete | 2022-05-09 | 2022-02-22 |
28/03/2025 | Vintage Pharmaceuticals-Charlotte |
U.S.A |
ENDO OPERATIONS LTD | 28358 | BISMUTH SUBCITRATE POTASSIUM | 2014-06-11 | Active | II | Complete | 2015-02-07 | 2014-06-13 |