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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/08/2025 | MSN Laboratories |
India |
MSN LABORATORIES PRIVATE LTD | 41469 | BELZUTIFAN | 2025-03-26 | Active | II | Complete | 2025-05-15 | 2025-03-28 |
28/08/2025 | APICORE LLC | 41515 | BELZUTIFAN | 2025-05-06 | Active | II | Complete | 2025-07-01 | 2025-05-27 |