Ropinirole Hydrochloride

Treats Parkinson’s disease. ANDA 90869, held by Actavis Elizabeth. Ropinirole Hydrochloride.

As of Nov 15, 2026, ANDA 90869 (Ropinirole Hydrochloride), held by Actavis Elizabeth, was first approved by FDA on May 17, 2012, with 1 approved supplement and 0 published complete response letters.

First approved: May 17, 2012
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 17, 2012	Original application	Approved	Review

Products

5 strengths and forms


Ropinirole HydrochlorideEQ 2MG BASE · tablet, extended release;oral	Ropinirole Hydrochloride	Rx
Ropinirole HydrochlorideEQ 4MG BASE · tablet, extended release;oral	Ropinirole Hydrochloride	Rx
Ropinirole HydrochlorideEQ 6MG BASE · tablet, extended release;oral	Ropinirole Hydrochloride	Rx
Ropinirole HydrochlorideEQ 8MG BASE · tablet, extended release;oral	Ropinirole Hydrochloride	Rx
Ropinirole HydrochlorideEQ 12MG BASE · tablet, extended release;oral	Ropinirole Hydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Sep 28, 2015	Supplement 11Labeling · Standard review	Approved	None posted
May 17, 2012	Original application	Approved	Review

Identifiers

Application: ANDA 90869
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters