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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