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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 Veranova
U.S.A
VERANOVA LP 15059 D-THREO-METHYLPHENIDATE HYDROCHLORIDE 2000-09-22 Active II N/A
28/03/2025 Alkem Laboratories
India
ALKEM LABORATORIES LTD 32902 DEXMETHYLPHENIDATE HYDROCHLORIDE 2018-06-23 Active II Complete 2018-09-10 2018-06-28