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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
31/10/2025 Veranova
U.S.A
VERANOVA LP 24049 SODIUM OXYBATE 2010-08-02 Active II Complete 2013-08-28 2012-12-19
31/10/2025 Granules India Limited
India
GRANULES INDIA LTD 39696 SODIUM OXYBATE 2025-03-31 Active II Complete 2025-05-13 2025-04-22