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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
29/07/2025 | Ami Lifesciences Private Limited |
India |
AMI LIFESCIENCES PRIVATE LTD | 36655 | BRIVARACETAM | 2022-01-08 | Active | II | N/A | ||
29/07/2025 | Lee Pharma |
India |
LEE PHARMA LTD | 39008 | BRIVARACETAM | 2023-10-09 | Active | II | Complete | 2025-05-28 | 2024-08-29 |