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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 Alkaloida Chemical Company Zrt
Hungary
ALKALOIDA CHEMICAL CO ZRT 34598 PHENOBARBITAL SODIUM, USP 2020-03-10 Active II Complete 2020-03-31 2020-03-06
28/03/2025 Harman Finochem
India
HARMAN FINOCHEM LTD 31499 PHENOBARBITAL SODIUM USP 2017-03-16 Active II N/A