APPLICATION
ANDA201047
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-06
LATEST ACTION
2020-04-17
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ROPINIROLE HYDROCHLORIDEPrescription
ROPINIROLE HYDROCHLORIDE EQ 8MG BASE · TABLET, EXTENDED RELEASE · ORAL
ROPINIROLE HYDROCHLORIDEPrescription
ROPINIROLE HYDROCHLORIDE EQ 4MG BASE · TABLET, EXTENDED RELEASE · ORAL
ROPINIROLE HYDROCHLORIDEPrescription
ROPINIROLE HYDROCHLORIDE EQ 2MG BASE · TABLET, EXTENDED RELEASE · ORAL
ROPINIROLE HYDROCHLORIDEPrescription
ROPINIROLE HYDROCHLORIDE EQ 12MG BASE · TABLET, EXTENDED RELEASE · ORAL
ROPINIROLE HYDROCHLORIDEPrescription
ROPINIROLE HYDROCHLORIDE EQ 6MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2020-04-17Labeling · Supplement 11 · standardAP
2015-09-22Labeling · Supplement 8 · standardAP
2012-06-06Not Applicable · OriginalAP
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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