Treats Parkinson’s disease (PD) and moderate-to-severe primary … Legs Syndrome (RLS). ANDA 79229, held by Orbion Pharms. Ropinirole Hydrochloride.
As of Nov 15, 2026, ANDA 79229 (Ropinirole Hydrochloride), held by Orbion Pharms, was first approved by FDA on Nov 28, 2012, 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 |
|---|---|---|---|
| Nov 28, 2012 | 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 |
| Oct 27, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 27, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 3, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 19, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 28, 2012 | 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
