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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 | Lee Pharma |
India |
LEE PHARMA LTD | 39582 | VILOXAZINE HYDROCHLORIDE | 2024-03-12 | Active | II | N/A | ||
29/07/2025 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PRIVATE LIMITED | 39333 | VILOXAZINE HYDROCHLORIDE | 2023-12-30 | Active | II | Complete | 2025-01-24 | 2024-12-24 |