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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
25/04/2025 Interquim SA
Spain
INTERQUIM SA 28471 ROFLUMILAST 2014-07-31 Active II Complete 2015-01-05 2014-07-23
25/04/2025 Alivus Life Sciences
India
ALIVUS LIFE SCIENCES LTD 39781 ROFLUMILAST USP 2024-03-28 Active II N/A