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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
24/02/2025 | Minakem |
France |
MINAKEM | 28441 | BUDESONIDE MICRONIZED | 2014-06-20 | Active | II | Complete | 2017-03-03 | 2017-02-10 |
24/02/2025 | Coral Drugs Private Limited |
India |
CORAL DRUGS PRIVATE LTD | 30534 | BUDESONIDE | 2017-02-02 | Active | II | N/A |