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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 | Symbiotec Pharmalab |
India |
SYMBIOTEC PHARMALAB PRIVATE LTD | 32728 | PREDNISOLONE ACETATE USP | 2018-06-04 | Active | II | Complete | 2020-05-19 | 2020-04-13 |
28/03/2025 | Axplora |
Germany |
FARMABIOS SPA | 32896 | STERILE PREDNISOLONE-21-ACETATE MICRONIZED | 2018-07-16 | Active | II | Complete | 2020-12-29 | 2020-09-22 |