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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 Apotex Pharmachem
Canada
APOTEX PHARMACHEM INC 31843 TASIMELTEON 2017-07-31 Active II Complete 2017-10-30 2017-07-26
28/03/2025 MSN Laboratories
India
MSN LIFE SCIENCES PRIVATE LTD 31948 TASIMELTEON 2017-08-30 Active II Complete 2017-10-05 2017-09-22