FdaApplication
NDA 021264
Identifiers
- fda_app_no: NDA021264
Properties
| Property | Value |
|---|---|
| applicant_name | MDD US OPERATIONS LLC |
| application_type | NDA |
| approval_date | 2004-04-20 |
Revenue by product
APOKYN
| Period | Revenue |
|---|---|
| Q2 2026 | $6.3M |
| Q1 2026 | $7.7M |
| Q4 2025 | $9.6M |
| Q3 2025 | $10.4M |
| Q2 2025 | $12.8M |
| Q1 2025 | $15.0M |
| Q4 2024 | $20.1M |
| Q3 2024 | $19.9M |
| Q2 2024 | $17.3M |
| Q1 2024 | $16.6M |
| Q4 2023 | $18.8M |
| Q3 2023 | $21.5M |
| Q2 2023 | $17.6M |
| Q1 2023 | $17.2M |
| Q4 2022 | $18.1M |
| Q3 2022 | $18.3M |
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 (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| APOKYN | APOMORPHINE HYDROCHLORIDE | 20MG/2ML (10MG/ML) | INJECTABLE;SUBCUTANEOUS |
| APOKYN | APOMORPHINE HYDROCHLORIDE | 30MG/3ML (10MG/ML) | INJECTABLE;SUBCUTANEOUS |
2 products