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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 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
28/03/2025 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 40004 VILOXAZINE HYDROCHLORIDE 2024-05-31 Active II N/A