Treats Parkinson’s disease (PD) and moderate-to-severe primary … Legs Syndrome (RLS). ANDA 78110, held by Prinston Inc. Ropinirole Hydrochloride.
As of Nov 15, 2026, ANDA 78110 (Ropinirole Hydrochloride), held by Prinston Inc, was first approved by FDA on May 5, 2008, with 10 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 Ropinirole tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 5, 2008 | 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 |
| Sep 16, 2025 | Supplement 21Labeling · Standard review | Approved | None posted |
| Sep 16, 2025 | Supplement 20Labeling · Standard review | Approved | None posted |
| Sep 16, 2025 | Supplement 18Labeling · Standard review | Approved | None posted |
| Feb 21, 2020 | Supplement 17Labeling · Standard review | Approved | None posted |
| Feb 21, 2020 | Supplement 14Labeling · Standard review | Approved | None posted |
| Feb 21, 2020 | Supplement 12Labeling · Standard review | Approved | None posted |
| Dec 11, 2015 | Supplement 11Manufacturing | Approved | None posted |
| Dec 11, 2015 | Supplement 6Labeling | Approved | None posted |
| Apr 13, 2015 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jul 11, 2008 | Supplement 1Labeling | Approved | None posted |
| May 5, 2008 | 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
