NDA 21853, held by Reliant Pharms. Omega-3acid Ethyl Esters.
As of Nov 14, 2026, NDA 21853 (Omacor), held by Reliant Pharms, was first approved by FDA on Jun 12, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2007 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Omacor1G · capsule; oral | Omega-3acid Ethyl Esters | Rx |
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
