ANDA 200431, held by Watson Labs Inc. Ropinirole Hydrochloride.
As of Nov 15, 2026, ANDA 200431 (Ropinirole Hydrochloride), held by Watson Labs Inc, was first approved by FDA on Jun 6, 2012, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 6, 2012 | Original application | Approved | None posted |
| Ropinirole HydrochlorideEQ 2MG BASE · tablet, extended release;oral | Ropinirole Hydrochloride | Discontinued |
| Ropinirole HydrochlorideEQ 4MG BASE · tablet, extended release;oral | Ropinirole Hydrochloride | Discontinued |
| Ropinirole HydrochlorideEQ 6MG BASE · tablet, extended release;oral | Ropinirole Hydrochloride | Discontinued |
| Ropinirole HydrochlorideEQ 8MG BASE · tablet, extended release;oral | Ropinirole Hydrochloride | Discontinued |
| Ropinirole HydrochlorideEQ 12MG BASE · tablet, extended release;oral | Ropinirole Hydrochloride | Discontinued |
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
