Ropinirole Hydrochloride

Treats Parkinson’s disease (PD) and moderate-to-severe primary … Legs Syndrome (RLS). ANDA 90429, held by Alembic Ltd. Ropinirole Hydrochloride.

As of Nov 15, 2026, ANDA 90429 (Ropinirole Hydrochloride), held by Alembic Ltd, was first approved by FDA on Mar 24, 2010, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 24, 2010
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ropinirole Tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2). 1.1 Parkinson's Disease

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Mar 24, 2010	Original application	Approved	None posted

Products

7 strengths and forms


Ropinirole HydrochlorideEQ 0.25MG BASE · tablet;oral	Ropinirole Hydrochloride	Rx
Ropinirole HydrochlorideEQ 0.5MG BASE · tablet;oral	Ropinirole Hydrochloride	Rx
Ropinirole HydrochlorideEQ 1MG BASE · tablet;oral	Ropinirole Hydrochloride	Rx
Ropinirole HydrochlorideEQ 2MG BASE · tablet;oral	Ropinirole Hydrochloride	Rx
Ropinirole HydrochlorideEQ 3MG BASE · tablet;oral	Ropinirole Hydrochloride	Rx
Ropinirole HydrochlorideEQ 4MG BASE · tablet;oral	Ropinirole Hydrochloride	Rx
Ropinirole HydrochlorideEQ 5MG BASE · tablet;oral	Ropinirole Hydrochloride	Rx

All 7 submissions, including labeling and manufacturing supplements


Sep 9, 2026	Supplement 19Labeling · Standard review	Approved	None posted
Sep 9, 2026	Supplement 16Labeling · Standard review	Approved	None posted
Apr 7, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Apr 7, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Nov 18, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Oct 31, 2011	Supplement 2Labeling	Approved	None posted
Mar 24, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90429
Drugs@FDA: Overview at FDA
Company: Alembic, LLC

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