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List of Drug Master Files (DMF) of rotigotine transdermal patch 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 26481 ROTIGOTINE 2012-09-26 Active II Complete 2021-10-14 2021-09-07
26/09/2024 Seqens
France
WAVELENGTH ENTERPRISES LTD 26236 ROTIGOTINE 2012-07-12 Active II Complete 2014-03-03 2013-01-28