APPLICATION
ANDA078110
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-05
LATEST ACTION
2025-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ROPINIROLE HYDROCHLORIDEPrescription
ROPINIROLE HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEPrescription
ROPINIROLE HYDROCHLORIDE EQ 2MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEPrescription
ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEPrescription
ROPINIROLE HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEPrescription
ROPINIROLE HYDROCHLORIDE EQ 3MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEPrescription
ROPINIROLE HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEPrescription
ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE · TABLET · ORAL
Approval history
2025-09-16Labeling · Supplement 18 · standardAP
2025-09-16Labeling · Supplement 20 · standardAP
2025-09-16Labeling · Supplement 21 · standardAP
2020-02-21Labeling · Supplement 14 · standardAP
2020-02-21Labeling · Supplement 12 · standardAP
2020-02-21Labeling · Supplement 17 · standardAP
2015-12-11Labeling · Supplement 6AP
2015-12-11Manufacturing (CMC) · Supplement 11 · unknownAP
2015-04-13Labeling · Supplement 9 · standardAP
2008-07-11Labeling · Supplement 1AP
2008-05-05OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.