FdaApplication
NDA 021687
Identifiers
- fda_app_no: NDA021687
Properties
| Property | Value |
|---|---|
| applicant_name | ORGANON LLC A SUB OF ORGANON AND CO |
| application_type | NDA |
| approval_date | 2004-07-23 |
Revenue by product
VYTORIN
| Period | Revenue |
|---|---|
| Q2 2026 | $21.0M* |
| Q1 2026 | $21.0M* |
| Q4 2025 | $25.0M* |
| Q3 2025 | $25.0M* |
| Q2 2025 | $27.0M* |
| Q1 2025 | $23.0M* |
| Q4 2024 | $26.0M* |
| Q3 2024 | $26.0M* |
| Q2 2024 | $28.0M* |
| Q1 2024 | $28.0M* |
| Q4 2023 | $29.0M* |
| Q3 2023 | $33.0M* |
| Q2 2023 | $38.0M* |
| Q1 2023 | $29.0M* |
| Q4 2022 | $26.0M* |
| Q3 2022 | $31.0M* |
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 (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| VYTORIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL |
| VYTORIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL |
| VYTORIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL |
| VYTORIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL |
4 products