← FDA DRUG APPROVALS

FDA ANDA · ANDA200462

ROPINIROLE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA

APPLICATION
ANDA200462
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-15
LATEST ACTION
2015-10-16
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 8MG BASE · TABLET, EXTENDED RELEASE · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 4MG BASE · TABLET, EXTENDED RELEASE · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 2MG BASE · TABLET, EXTENDED RELEASE · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 12MG BASE · TABLET, EXTENDED RELEASE · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 6MG BASE · TABLET, EXTENDED RELEASE · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 3MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2015-10-16Labeling · Supplement 4 · standardAP
2012-10-15Not Applicable · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →