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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 | 5500 | TAMOXIFEN CITRATE USP | 1984-08-15 | Active | II | Complete | 2014-10-01 | 2013-10-24 |
28/03/2025 | Astellas Pharma |
Japan |
FUJISAWA DEUTSCHLAND GMBH | 5060 | TAMOXIFEN CITRATE | 1983-06-13 | Inactive | II | N/A |