Ropinirole Hydrochloride

ANDA 91395, held by Chartwell Rx. Ropinirole Hydrochloride.

As of Nov 15, 2026, ANDA 91395 (Ropinirole Hydrochloride), held by Chartwell Rx, was first approved by FDA on Aug 27, 2012, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 27, 2012
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Aug 27, 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 3 submissions, including labeling and manufacturing supplements


Jan 22, 2026	Supplement 2Labeling · Standard review	Approved	None posted
Jan 22, 2026	Supplement 1Labeling · Standard review	Approved	None posted
Aug 27, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 91395
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