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FDA ANDA · ANDA090411

ROPINIROLE HYDROCHLORIDE

Sponsor: ZYDUS LIFESCIENCES

APPLICATION
ANDA090411
TYPE
ANDA
ORIGINAL APPROVAL
2009-06-01
LATEST ACTION
2025-09-30
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

2025-09-30Labeling · Supplement 7 · standardAP
2020-04-07Labeling · Supplement 6 · standardAP
2015-10-28Labeling · Supplement 5 · standardAP
2013-08-30Labeling · Supplement 2 · standardAP
2011-08-15Labeling · Supplement 1AP
2009-06-01OriginalAP
VIEW ON DRUGS@FDA ↗

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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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