Ropinirole Hydrochloride

Treats Parkinson’s disease. ANDA 201576, held by Dr Reddys Labs Ltd. Ropinirole Hydrochloride.

As of Nov 15, 2026, ANDA 201576 (Ropinirole Hydrochloride), held by Dr Reddys Labs Ltd, was first approved by FDA on Jun 6, 2012, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 6, 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 non-ergoline dopamine agonist 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
Jun 6, 2012	Original application	Approved	None posted

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


Oct 19, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Jun 6, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201576
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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