NDA 19922, held by Hospira. Fenoldopam Mesylate.
As of Nov 13, 2026, NDA 19922 (Corlopam), held by Hospira, was first approved by FDA on Sep 23, 1997, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 1, 2004 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Sep 23, 1997 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| CorlopamEQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Fenoldopam Mesylate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 2, 2020 | Supplement 19Labeling · Standard review | Approved | |
| Dec 17, 2015 | Supplement 16Labeling · Standard review | Approved | |
| Mar 22, 2006 | Supplement 10Manufacturing | Approved | None posted |
| Apr 1, 2004 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Jul 6, 2000 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 13, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 23, 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
