Treats Parkinson's disease. ANDA 217862, held by Elite Labs Inc. Ropinirole Hydrochloride.
As of Nov 15, 2026, ANDA 217862 (Ropinirole Hydrochloride), held by Elite Labs Inc, was first approved by FDA on Nov 10, 2025, with 0 approved supplements and 0 published complete response letters.
Ropinirole extended-release tablets are indicated for the treatment of Parkinson's disease. Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 10, 2025 | Original application | Approved | None posted |
| 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 |
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
