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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 Neuland Laboratories
India
NEULAND LABORATORIES LTD 19590 ROPINIROLE HYDROCHLORIDE USP 2006-07-10 Active II N/A
28/03/2025 Actavis Inc
Ireland
TEVA PHARMACEUTICAL INDUSTRIES LTD 21331 ROPINIROLE HYDROCHLORIDE USP 2008-02-07 Inactive II N/A