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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
24/02/2025 Alkaloida Chemical Company Zrt
Hungary
ALKALOIDA CHEMICAL CO ZRT 4642 PHENOBARBITAL USP 1982-09-01 Active II N/A
24/02/2025 F. Hoffmann-La Roche
Switzerland
KV PHARMACEUTICAL CO 3756 HYOSCYAMINE SO4 & HYOSCYAMINE S04 W/PHENOBARBITAL SR CAPS-KREMERS 1980-02-28 Inactive II N/A