Ropinirole Hydrochloride

Treats Parkinson’s disease (PD) and moderate- to-severe primary … Legs Syndrome (RLS). ANDA 79165, held by Mlv. Ropinirole Hydrochloride.

As of Nov 15, 2026, ANDA 79165 (Ropinirole Hydrochloride), held by Mlv, was first approved by FDA on Feb 7, 2012, with 6 approved supplements and 0 published complete response letters.

First approved: Feb 7, 2012
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ropinirole tablet is 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 7, 2012	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 28, 2022	Supplement 7Labeling · Standard review	Approved	None posted
Oct 28, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Apr 2, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Apr 2, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Oct 19, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Oct 19, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Feb 7, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 79165
Drugs@FDA: Overview at FDA
Company: MLV

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