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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/11/2024 | Aspen API |
Netherlands |
ASPEN OSS BV | 14540 | TESTOSTERONE UNDECANOATE | 1999-11-18 | Active | II | Complete | 2018-04-26 | 2015-09-24 |
28/11/2024 | Symbiotec Pharmalab |
India |
SYMBIOTEC PHARMALAB PRIVATE LTD | 25534 | TESTOSTERONE UNDECANOATE | 2011-11-28 | Active | II | Complete | 2023-11-02 | 2023-10-03 |
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