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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