APPLICATION
ANDA090135
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-25
LATEST ACTION
2022-10-27
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
2022-10-27Labeling · Supplement 11 · standardAP
2020-08-06Labeling · Supplement 8 · standardAP
2020-08-06Labeling · Supplement 10 · standardAP
2020-08-06Labeling · Supplement 9 · standardAP
2015-11-17Labeling · Supplement 7 · standardAP
2012-02-23Labeling · Supplement 1AP
2010-02-25OriginalAP
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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