APPLICATION
ANDA077852
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-05
LATEST ACTION
2024-04-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 3MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 2MG BASE · TABLET · ORAL
Approval history
2024-04-04Labeling · Supplement 13 · standardAP
2024-04-04Labeling · Supplement 12 · standardAP
2021-03-26Labeling · Supplement 9 · standardAP
2021-03-26Labeling · Supplement 11 · standardAP
2015-10-19Labeling · Supplement 8 · standardAP
2012-09-07Labeling · Supplement 6AP
2011-08-15Labeling · Supplement 4AP
2009-11-17Labeling · Supplement 3AP
2008-05-21Labeling · Supplement 2AP
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.
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