← FDA DRUG APPROVALS

FDA ANDA · ANDA078230

ROPINIROLE HYDROCHLORIDE

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA078230
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-20
LATEST ACTION
2020-03-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 3MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 2MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE · TABLET · ORAL

Approval history

2020-03-04Labeling · Supplement 8 · standardAP
2020-03-04Labeling · Supplement 9 · standardAP
2020-03-04Labeling · Supplement 7 · standardAP
2011-10-31Labeling · Supplement 5AP
2010-04-28Labeling · Supplement 3AP
2009-11-30Labeling · Supplement 2AP
2008-05-20OriginalAP
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 →