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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 | Chongqing Carelife Pharmaceutical |
China |
CHONGQING CARELIFE PHARMACEUTICAL CO LTD | 38816 | DACOMITINIB | 2023-11-24 | Active | II | Complete | 2024-09-30 | 2024-08-26 |
| 28/03/2025 | MSN Laboratories |
India |
MSN LABORATORIES PRIVATE LTD | 35213 | DACOMITINIB MONOHYDRATE | 2020-09-29 | Active | II | N/A |
