NDA 20658, held by Glaxosmithkline LLC. Ropinirole Hydrochloride.
As of Nov 13, 2026, NDA 20658 (Requip), held by Glaxosmithkline LLC, was first approved by FDA on Sep 19, 1997, with 24 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 4, 2005 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Sep 19, 1997 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| RequipEQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ropinirole Hydrochloride | DiscontinuedReference drug |
| RequipEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ropinirole Hydrochloride | DiscontinuedReference drug |
| RequipEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ropinirole Hydrochloride | DiscontinuedReference drug |
| RequipEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ropinirole Hydrochloride | DiscontinuedReference drug |
| RequipEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ropinirole Hydrochloride | DiscontinuedReference drug |
| RequipEQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ropinirole Hydrochloride | DiscontinuedReference drug |
| RequipEQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ropinirole Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 12, 2021 | Supplement 38Labeling · Standard review | Approved | |
| Apr 3, 2020 | Supplement 37Labeling | Approved | |
| May 5, 2017 | Supplement 34Labeling · Standard review | Approved | |
| Sep 9, 2016 | Supplement 33Labeling · Standard review | Approved | |
| Aug 28, 2014 | Supplement 32Labeling · Standard review | Approved | |
| Aug 28, 2014 | Supplement 30Labeling | Approved | |
| Aug 28, 2014 | Supplement 27Labeling · Standard review | Approved | |
| Aug 28, 2014 | Supplement 26Labeling · Standard review | Approved | |
| Aug 28, 2014 | Supplement 24Labeling · Standard review | Approved | |
| Mar 19, 2012 | Supplement 31Labeling · Standard review | Approved | |
| Dec 31, 2008 | Supplement 21Labeling · Standard review | Approved | |
| Dec 31, 2008 | Supplement 20Labeling · Standard review | Approved | |
| Dec 31, 2008 | Supplement 18Labeling · Standard review | Approved | |
| May 4, 2005 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Jun 19, 2003 | Supplement 12Labeling · Standard review | Approved | |
| Oct 22, 2002 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jul 5, 2001 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Apr 3, 2001 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Mar 1, 2001 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 15, 2000 | Supplement 7Labeling · Standard review | Approved | None posted |
| May 15, 2000 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 2, 1999 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Aug 16, 1999 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jan 27, 1999 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 19, 1997 | Original applicationNew molecular entity · Standard review | Approved |
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
