Treats Parkinson’s disease (PD) and moderate-to-severe primary … Legs Syndrome (RLS). ANDA 204022, held by Accord Hlthcare. Ropinirole Hydrochloride.
As of Nov 15, 2026, ANDA 204022 (Ropinirole Hydrochloride), held by Accord Hlthcare, was first approved by FDA on Feb 28, 2017, with 4 approved supplements and 0 published complete response letters.
Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1, 1.2 ) 1.1 Parkinson’s Disease
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2017 | Original application | Approved | None posted |
| 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 |
| Mar 18, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| May 6, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 26, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 26, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 28, 2017 | Original application | Approved | None posted |
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
