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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 22859 | TOPOTECAN HCL | 2010-06-30 | Active | II | Complete | 2013-10-07 | 2013-09-26 |
| 31/10/2025 | Cipla |
India |
CIPLA LTD | 21621 | TOPOTECAN HYDROCHLORIDE | 2008-07-17 | Inactive | II | N/A |
