Drug application
ORIAHNN (COPACKAGED) (ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE, ELAGOLIX SODIUM)
Drugs@FDA NDA 213388 · ABBVIE
Key facts
| Drug name | ORIAHNN (COPACKAGED) |
|---|---|
| Active ingredients | ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE, ELAGOLIX SODIUM |
| Application type | NDA |
| Application number | 213388 |
| Company | ABBVIE |
| Dosage forms | CAPSULE, ORAL |
| Strength | EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | May 29, 2020 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: