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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 Cadila Pharmaceuticals
India
CADILA LABORATORIES PVT LTD 7348 PHENYTOIN USP & PHENYTOIN SODIUM USP 1988-02-25 Inactive II N/A
28/03/2025 Divis Laboratories
India
DIVIS LABORATORIES LTD 15848 5-PHENYLHYDANTOIN 2002-01-31 Inactive II N/A