ANDA 78230, held by Epic Pharma LLC. Ropinirole Hydrochloride.
As of Nov 15, 2026, ANDA 78230 (Ropinirole Hydrochloride), held by Epic Pharma LLC, was first approved by FDA on May 20, 2008, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 20, 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 |
| Mar 4, 2020 | Supplement 7Labeling · Standard review | Approved | None posted |
| Mar 4, 2020 | Supplement 8Labeling · Standard review | Approved | None posted |
| Mar 4, 2020 | Supplement 9Labeling · Standard review | Approved | None posted |
| Oct 31, 2011 | Supplement 5Labeling | Approved | None posted |
| Apr 28, 2010 | Supplement 3Labeling | Approved | None posted |
| Nov 30, 2009 | Supplement 2Labeling | Approved | None posted |
| May 20, 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
