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List of Drug Master Files (DMF) of Tolterodine Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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
26/09/2024 Interquim SA
Spain
INTERQUIM SA 19599 TOLTERODINE TARTRATE 2006-07-14 Active II Complete 2013-04-23 2013-04-10
26/09/2024 Amino Chemicals
Malta
AMINO CHEMICALS LTD 20093 TOLTERODINE TARTRATE 2006-12-21 Active II N/A