Manages heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in…. NDA 213388, held by Abbvie. Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium.
As of Nov 13, 2026, NDA 213388 (Oriahnn (Copackaged)), held by Abbvie, was first approved by FDA on May 29, 2020, with 4 approved supplements and 0 published complete response letters.
ORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitation of Use: Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 29, 2020 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oriahnn (Copackaged)EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE · capsule;oral | Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium | RxReference drug |
| Dec 17, 2025 | Supplement 6Labeling · Standard review | Approved | |
| Jul 30, 2024 | Supplement 5Manufacturing | Approved | |
| Jun 5, 2023 | Supplement 3Labeling · Standard review | Approved | |
| Aug 2, 2021 | Supplement 1Labeling · Standard review | Approved | |
| May 29, 2020 | Original applicationNew combination · 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
