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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 | Sanofi |
France |
ROUSSELL UCLAF | 3072 | ESTRADIOL VALERATE | 1977-11-09 | Inactive | II | N/A | ||
| 28/03/2025 | Aspen API |
Netherlands |
ASPEN OSS BV | 12268 | ESTRADIOL VALERATE | 1996-12-16 | Active | II | Complete | 2015-01-06 | 2014-12-22 |
