FdaApplication
NDA 212690
Identifiers
- fda_app_no: NDA212690
Properties
| Property | Value |
|---|---|
| applicant_name | JAZZ PHARMACEUTICALS IRELAND LTD |
| application_type | NDA |
| approval_date | 2020-07-21 |
Revenue by product
XYWAV
| Period | Revenue |
|---|---|
| Q2 2026 | $471.2M* |
| Q1 2026 | $408.2M* |
| Q4 2025 | $465.5M* |
| Q3 2025 | $431.4M* |
| Q2 2025 | $415.3M* |
| Q1 2025 | $344.8M* |
| Q4 2024 | $401.0M* |
| Q3 2024 | $388.5M* |
| Q2 2024 | $368.5M* |
| Q1 2024 | $315.3M* |
| Q4 2023 | $337.0M* |
| Q3 2023 | $331.6M* |
| Q2 2023 | $326.6M* |
| Q1 2023 | $277.8M* |
| Q4 2022 | $281.4M* |
| Q3 2022 | $255.9M* |
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 |
|---|---|---|---|
| XYWAV | CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE | 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | SOLUTION;ORAL |
1 product