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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
28/10/2024 Noramco
U.S.A
NORAMCO LLC 21084 TAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE 2008-01-23 Active II Complete 2020-08-05 2020-07-30
28/10/2024 Alkem Laboratories
India
ALKEM LABORATORIES LTD 31435 TAPENTADOL HYDROCHLORIDE 2017-03-27 Active II Complete 2017-08-18 2017-03-30