Ropinirole Hydrochloride

ANDA 90411, held by Zydus Lifesciences. Ropinirole Hydrochloride.

As of Nov 15, 2026, ANDA 90411 (Ropinirole Hydrochloride), held by Zydus Lifesciences, was first approved by FDA on Jun 1, 2009, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 1, 2009
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
Jun 1, 2009	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


Sep 30, 2025	Supplement 7Labeling · Standard review	Approved	None posted
Apr 7, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Oct 28, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Aug 30, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Aug 15, 2011	Supplement 1Labeling	Approved	None posted
Jun 1, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90411
Drugs@FDA: Overview at FDA
Company: Zydus Lifesciences

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