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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | Enaltec Labs |
India |
ENALTEC LABS PRIVATE LTD | 28230 | TROSPIUM CHLORIDE USP | 2014-09-11 | Active | II | Complete | 2014-12-22 | 2014-09-04 |
| 29/11/2025 | Maithri Drugs |
India |
MAITHRI DRUGS PRIVATE LTD | 41847 | TROSPIUM CHLORIDE USP | 2025-04-30 | Active | II | N/A |
