Ropinirole Hydrochloride

Treats Parkinson’s disease (PD) and moderate-to-severe primary … Legs Syndrome (RLS). ANDA 90135, held by Glenmark Pharms Ltd. Ropinirole Hydrochloride.

As of Nov 15, 2026, ANDA 90135 (Ropinirole Hydrochloride), held by Glenmark Pharms Ltd, was first approved by FDA on Feb 25, 2010, with 6 approved supplements and 0 published complete response letters.

First approved: Feb 25, 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
Feb 25, 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


Oct 27, 2022	Supplement 11Labeling · Standard review	Approved	None posted
Aug 6, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Aug 6, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Aug 6, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Nov 17, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Feb 23, 2012	Supplement 1Labeling	Approved	None posted
Feb 25, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90135
Drugs@FDA: Overview at FDA
Company: Glenmark Pharmaceuticals

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