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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 C-Squared Pharma
Ireland
C-SQUARED PHARMA LTD 36342 CYCLOPENTOLATE HYDROCHLORIDE 2021-10-22 Active II Complete 2022-01-21 2021-12-08
28/03/2025 UQUIFA
Spain
ESTEVE QUIMICA SA 7272 CYCLOPENTOLATE HYDROCHLORIDE 1987-12-31 Active II Complete 2013-10-31 2013-07-26