FdaApplication
NDA 021196
Identifiers
- fda_app_no: NDA021196
Properties
| Property | Value |
|---|---|
| applicant_name | JAZZ PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2002-07-17 |
Revenue by product
XYREM
| Period | Revenue |
|---|---|
| Q2 2026 | $30.5M |
| Q1 2026 | $31.2M |
| Q4 2025 | $37.8M |
| Q3 2025 | $35.7M |
| Q2 2025 | $35.3M |
| Q1 2025 | $37.2M |
| Q4 2024 | $49.3M |
| Q3 2024 | $58.1M |
| Q2 2024 | $62.2M |
| Q1 2024 | $64.2M |
| Q4 2023 | $106.7M |
| Q3 2023 | $125.1M |
| Q2 2023 | $159.8M |
| Q1 2023 | $178.1M |
| Q4 2022 | $247.5M |
| Q3 2022 | $256.0M |
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 |
|---|---|---|---|
| XYREM | SODIUM OXYBATE | 0.5GM/ML | SOLUTION;ORAL |
1 product