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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 Malladi Drugs & Pharmaceuticals Limited
India
MALLADI DRUGS AND PHARMACEUTICALS LTD 38487 DOXYLAMINE SUCCINATE 2023-12-26 Active II Complete 2024-07-03 2024-06-14
28/03/2025 Archimica
Italy
ARCHIMICA SPA 7215 DOXYLAMINE SUCCINATE USP 1987-10-28 Inactive II N/A