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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
25/04/2025 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 32812 | MICAFUNGIN SODIUM | 2018-06-17 | Active | II | Complete | 2018-10-29 | 2018-05-14 |
25/04/2025 | Astellas Pharma |
Japan |
ASTELLAS PHARMA INC | 12856 | FK463 DRUG SUBSTANCE | 1998-02-11 | Active | II | N/A |