← FDA DRUG APPROVALS

FDA ANDA · ANDA090869

ROPINIROLE

Sponsor: ACTAVIS ELIZABETH

APPLICATION
ANDA090869
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-17
LATEST ACTION
2015-09-28
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 12MG BASE · TABLET, EXTENDED RELEASE · ORAL
ROPINIROLE HYDROCHLORIDEPrescription
ROPINIROLE HYDROCHLORIDE EQ 6MG BASE · TABLET, EXTENDED RELEASE · ORAL
ROPINIROLE HYDROCHLORIDEPrescription
ROPINIROLE HYDROCHLORIDE EQ 2MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2015-09-28Labeling · Supplement 11 · standardAP
2012-05-17Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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