Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.
| Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/10/2024 | MSN Laboratories |
India |
MSN LABORATORIES PRIVATE LTD | 34652 | NERATINIB MALEATE (MONOHYDRATE) | 2020-02-28 | Active | II | N/A | ||
| 28/10/2024 | Teva Pharmaceutical Industries |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 35457 | NERATINIB MALEATE MONOHYDRATE | 2021-01-11 | Active | II | Complete | 2021-04-27 | 2020-12-17 |
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