Ropinirole Hydrochloride

Treats Parkinson’s disease. ANDA 204413, held by Prinston. Ropinirole Hydrochloride.

As of Nov 15, 2026, ANDA 204413 (Ropinirole Hydrochloride), held by Prinston, was first approved by FDA on May 11, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: May 11, 2022
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 11, 2022	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


Mar 31, 2025	Supplement 1Labeling · Standard review	Approved	None posted
May 11, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 204413
Drugs@FDA: Overview at FDA
Company: Prinston Pharmaceutical

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