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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 | MSN Laboratories |
India |
MSN LABORATORIES PRIVATE LTD | 34652 | NERATINIB MALEATE (MONOHYDRATE) | 2020-02-28 | Active | II | N/A | ||
| 28/03/2025 | Teva Pharmaceutical Industries |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 35457 | NERATINIB MALEATE MONOHYDRATE | 2021-01-11 | Active | II | Complete | 2021-04-27 | 2020-12-17 |
