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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 |