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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 | Symbiotec Pharmalab |
India |
SYMBIOTEC PHARMALAB PRIVATE LTD | 30747 | HYDROXYPROGESTERONE CAPROATE USP | 2016-07-19 | Active | II | Complete | 2017-06-16 | 2017-01-30 |
28/03/2025 | Aspen API |
Netherlands |
ASPEN OSS BV | 17113 | HYDROXYPROGESTERONE CAPROATE | 2004-01-21 | Active | II | Complete | 2017-02-01 | 2017-01-09 |