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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 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 34836 | LAPATINIB DITOSYLATE MONOHYDRATE | 2021-02-05 | Active | II | N/A | ||
| 28/03/2025 | Minakem (formerly Delmar Chemicals) |
Canada |
DELMAR CHEMICALS INC | 32266 | LAPATINIB DITOSYLATE | 2018-01-17 | Active | II | Complete | 2018-12-03 | 2018-01-24 |
