ANDA 78881, held by Pharmobedient. Ropinirole Hydrochloride.
As of Nov 15, 2026, ANDA 78881 (Ropinirole Hydrochloride), held by Pharmobedient, was first approved by FDA on May 5, 2008, with 8 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 5, 2008 | Original application | Approved | None posted |
| Ropinirole HydrochlorideEQ 0.25MG BASE · tablet;oral | Ropinirole Hydrochloride | Discontinued |
| Ropinirole HydrochlorideEQ 0.5MG BASE · tablet;oral | Ropinirole Hydrochloride | Discontinued |
| Ropinirole HydrochlorideEQ 1MG BASE · tablet;oral | Ropinirole Hydrochloride | Discontinued |
| Ropinirole HydrochlorideEQ 2MG BASE · tablet;oral | Ropinirole Hydrochloride | Discontinued |
| Ropinirole HydrochlorideEQ 3MG BASE · tablet;oral | Ropinirole Hydrochloride | Discontinued |
| Ropinirole HydrochlorideEQ 4MG BASE · tablet;oral | Ropinirole Hydrochloride | Discontinued |
| Ropinirole HydrochlorideEQ 5MG BASE · tablet;oral | Ropinirole Hydrochloride | Discontinued |
| Nov 2, 2023 | Supplement 25Labeling · Standard review | Approved | None posted |
| Dec 7, 2020 | Supplement 22Labeling · Standard review | Approved | None posted |
| Mar 3, 2020 | Supplement 18Labeling · Standard review | Approved | None posted |
| Mar 3, 2020 | Supplement 20Labeling · Standard review | Approved | None posted |
| Oct 19, 2015 | Supplement 14Labeling · Standard review | Approved | None posted |
| Feb 22, 2012 | Supplement 8Labeling | Approved | None posted |
| Nov 30, 2009 | Supplement 4Labeling | Approved | None posted |
| May 19, 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
