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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 | 3877 | TESTOSTERONE ENANTHATE | 1980-06-25 | Active | II | N/A | ||
28/03/2025 | Symbiotec Pharmalab |
India |
SYMBIOTEC PHARMALAB PRIVATE LTD | 26166 | TESTOSTERONE ENANTHATE, USP | 2012-06-19 | Active | II | Complete | 2018-09-26 | 2018-04-17 |