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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
28/10/2024 Centrient Pharmaceuticals
Netherlands
CENTRIENT PHARMACEUTICALS NETHERLANDS BV 31410 ROSUVASTATIN CALCIUM 2017-03-28 Active II Complete 2017-11-17 2017-05-23
28/10/2024 Minakem (formerly Delmar Chemicals)
Canada
DELMAR CHEMICALS INC 29190 ROSUVASTATIN CALCIUM 2015-12-03 Active II Complete 2016-04-08 2015-09-25