FdaApplication
NDA 021312
Identifiers
- fda_app_no: NDA021312
Properties
| Property | Value |
|---|---|
| applicant_name | ORGANON LLC A SUB OF ORGANON AND CO |
| application_type | NDA |
| approval_date | 2002-06-26 |
Revenue by product
CLARINEX
| Period | Revenue |
|---|---|
| Q2 2026 | $30.0M |
| Q1 2026 | $31.0M |
| Q4 2025 | $30.0M |
| Q3 2025 | $25.0M |
| Q2 2025 | $34.0M |
| Q1 2025 | $34.0M |
| Q4 2024 | $27.0M |
| Q3 2024 | $27.0M |
| Q2 2024 | $35.0M |
| Q1 2024 | $37.0M |
| Q4 2023 | $29.0M |
| Q3 2023 | $28.0M |
| Q2 2023 | $39.0M |
| Q1 2023 | $39.0M |
| Q4 2022 | $26.0M |
| Q3 2022 | $26.0M |
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 (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CLARINEX | DESLORATADINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
| CLARINEX | DESLORATADINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
2 products