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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 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 20730 | CEFDINIR HYDRATE | 2007-06-28 | Active | II | N/A | ||
28/03/2025 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 39540 | CEFDINIR USP (ANHYDROUS) | 2024-03-25 | Active | II | Complete | 2024-04-19 | 2024-02-23 |