Ropinirole Hydrochloride

ANDA 201047, held by Sandoz Inc. Ropinirole Hydrochloride.

As of Nov 15, 2026, ANDA 201047 (Ropinirole Hydrochloride), held by Sandoz Inc, was first approved by FDA on Jun 6, 2012, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 6, 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
Jun 6, 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


Apr 17, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Sep 22, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Jun 6, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201047
Drugs@FDA: Overview at FDA
Company: Sandoz

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