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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 | 23899 | PREDNISOLONE SODIUM PHOSPHATE USP | 2010-06-18 | Active | II | Complete | 2016-06-10 | 2016-05-27 |
28/03/2025 | ACS DOBFAR SPA |
Italy |
ANTIBIOTICOS SPA | 2376 | PREDNISOLONE SODIUM PHOSPHATE BULK | 1974-12-18 | Inactive | II | N/A |