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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 | Axplora |
Germany |
FARMABIOS SPA | 14136 | FLUDROCORTISONE ACETATE | 1999-05-12 | Active | II | N/A | ||
28/03/2025 | Nuray Chemicals Private Limited |
India |
NOVITIUM PHARMA LLC | 34923 | FLUDROCORTISONE ACETATE USP | 2020-06-09 | Active | II | Complete | 2020-06-17 | 2020-06-08 |