FdaApplication
NDA 213388
Identifiers
- fda_app_no: NDA213388
Properties
| Property | Value |
|---|---|
| applicant_name | ABBVIE INC |
| application_type | NDA |
| approval_date | 2020-05-29 |
Revenue by product
ORIAHNN (COPACKAGED)
| Period | Revenue |
|---|---|
| Q4 2021 | $39.0M* |
| Q3 2021 | $38.0M* |
| Q2 2021 | $38.0M* |
| Q1 2021 | $30.0M* |
| Q4 2020 | $38.0M* |
| Q3 2020 | $25.0M* |
| Q2 2020 | $31.0M* |
| Q1 2020 | $31.0M* |
| Q4 2019 | $34.0M* |
| Q3 2019 | $27.0M* |
| Q2 2019 | $19.0M* |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients. A fourth quarter is the reported full year less nine months, since no filing states one.
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ORIAHNN (COPACKAGED) | ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM | EQ 300MG BASE,1MG,0.5MG;EQ 300MG BASE | CAPSULE;ORAL |
1 product