Ropinirole Hydrochloride

ANDA 200462, held by Aurobindo Pharma USA. Ropinirole Hydrochloride.

As of Nov 15, 2026, ANDA 200462 (Ropinirole Hydrochloride), held by Aurobindo Pharma USA, was first approved by FDA on Oct 15, 2012, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 15, 2012
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 15, 2012	Original application	Approved	None posted

Products

6 strengths and forms


Ropinirole HydrochlorideEQ 2MG BASE · tablet, extended release;oral	Ropinirole Hydrochloride	Discontinued
Ropinirole HydrochlorideEQ 3MG BASE · tablet, extended release;oral	Ropinirole Hydrochloride	Discontinued
Ropinirole HydrochlorideEQ 4MG BASE · tablet, extended release;oral	Ropinirole Hydrochloride	Discontinued
Ropinirole HydrochlorideEQ 6MG BASE · tablet, extended release;oral	Ropinirole Hydrochloride	Discontinued
Ropinirole HydrochlorideEQ 8MG BASE · tablet, extended release;oral	Ropinirole Hydrochloride	Discontinued
Ropinirole HydrochlorideEQ 12MG BASE · tablet, extended release;oral	Ropinirole Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Oct 16, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Oct 15, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 200462
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma USA

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