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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 | Aspen API |
Netherlands |
ASPEN OSS BV | 12141 | ESTRIOL | 1996-09-23 | Active | II | N/A | ||
28/03/2025 | Bayer AG |
Germany |
PROQUINA SA | 12476 | ESTRIOL | 1997-04-18 | Inactive | II | N/A |