Ropinirole Hydrochloride

ANDA 77460, held by Cosette Pharms Nc. Ropinirole Hydrochloride.

As of Nov 15, 2026, ANDA 77460 (Ropinirole Hydrochloride), held by Cosette Pharms Nc, was first approved by FDA on May 5, 2008, with 3 approved supplements and 0 published complete response letters.

First approved: May 5, 2008
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
May 5, 2008	Original application	Approved	Label Letter

Products

7 strengths and forms


Ropinirole HydrochlorideEQ 0.25MG BASE · tablet;oral	Ropinirole Hydrochloride	Discontinued
Ropinirole HydrochlorideEQ 0.5MG BASE · tablet;oral	Ropinirole Hydrochloride	Discontinued
Ropinirole HydrochlorideEQ 1MG BASE · tablet;oral	Ropinirole Hydrochloride	Discontinued
Ropinirole HydrochlorideEQ 2MG BASE · tablet;oral	Ropinirole Hydrochloride	Discontinued
Ropinirole HydrochlorideEQ 3MG BASE · tablet;oral	Ropinirole Hydrochloride	Discontinued
Ropinirole HydrochlorideEQ 4MG BASE · tablet;oral	Ropinirole Hydrochloride	Discontinued
Ropinirole HydrochlorideEQ 5MG BASE · tablet;oral	Ropinirole Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Mar 3, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Nov 17, 2009	Supplement 4Labeling	Approved	None posted
May 19, 2008	Supplement 2Labeling	Approved	None posted
May 5, 2008	Original application	Approved	Label Letter

Identifiers

Application: ANDA 77460
Drugs@FDA: Overview at FDA
Company: Cosette Pharmaceuticals

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