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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | Hetero Drugs |
India |
HETERO LABS LTD | 39380 | BOSUTINIB MONOHYDRATE | 2024-05-09 | Active | II | N/A | ||
| 29/11/2025 | MSN Laboratories |
India |
MSN LABORATORIES PRIVATE LTD | 30683 | BOSUTINIB MONOHYDRATE (FORM-I) | 2016-07-08 | Active | II | Complete | 2025-07-28 | 2025-07-08 |
