Ropinirole Hydrochloride

ANDA 79050, held by Chartwell Rx. Ropinirole Hydrochloride.

As of Nov 15, 2026, ANDA 79050 (Ropinirole Hydrochloride), held by Chartwell Rx, was first approved by FDA on May 29, 2008, with 5 approved supplements and 0 published complete response letters.

First approved: May 29, 2008
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 29, 2008	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 6 submissions, including labeling and manufacturing supplements


Oct 26, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Dec 1, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Mar 3, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Jan 9, 2013	Supplement 3Labeling · Standard review	Approved	None posted
Nov 7, 2011	Supplement 2Labeling	Approved	None posted
May 29, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 79050
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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