FdaApplication
NDA 214056
Identifiers
- fda_app_no: NDA214056
Properties
| Property | Value |
|---|---|
| applicant_name | MDD US OPERATIONS LLC A SUB OF SUPERNUS PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2025-02-03 |
Revenue by product
ONAPGO
| Period | Revenue |
|---|---|
| Q2 2026 | $13.5M |
| Q1 2026 | $8.4M |
| Q4 2025 | $8.8M |
| Q3 2025 | $6.8M |
| Q2 2025 | $1.6M |
| Q1 2025 | $0.0M |
| Q4 2024 | $0.0M |
| Q3 2024 | $0.0M |
| Q2 2024 | $0.0M |
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 |
|---|---|---|---|
| ONAPGO | APOMORPHINE HYDROCHLORIDE | 98MG/20ML (4.9MG/ML) | SOLUTION;SUBCUTANEOUS |
1 product