ANDA 77852, held by Hikma. Ropinirole Hydrochloride.
As of Nov 15, 2026, ANDA 77852 (Ropinirole Hydrochloride), held by Hikma, was first approved by FDA on May 5, 2008, with 9 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 |
| Apr 4, 2024 | Supplement 12Labeling · Standard review | Approved | None posted |
| Apr 4, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| Mar 26, 2021 | Supplement 9Labeling · Standard review | Approved | None posted |
| Mar 26, 2021 | Supplement 11Labeling · Standard review | Approved | None posted |
| Oct 19, 2015 | Supplement 8Labeling · Standard review | Approved | None posted |
| Sep 7, 2012 | Supplement 6Labeling | Approved | None posted |
| Aug 15, 2011 | Supplement 4Labeling | Approved | None posted |
| Nov 17, 2009 | Supplement 3Labeling | Approved | None posted |
| May 21, 2008 | Supplement 2Labeling | 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
