FdaApplication
NDA 021409
Identifiers
- fda_app_no: NDA021409
Properties
| Property | Value |
|---|---|
| applicant_name | ORGANON LLC A SUB OF ORGANON AND CO |
| application_type | NDA |
| approval_date | 2002-07-26 |
Revenue by product
SINGULAIR
| Period | Revenue |
|---|---|
| Q2 2026 | $48.0M |
| Q1 2026 | $40.0M |
| Q4 2025 | $59.0M |
| Q3 2025 | $53.0M |
| Q2 2025 | $66.0M |
| Q1 2025 | $74.0M |
| Q4 2024 | $84.0M |
| Q3 2024 | $85.0M |
| Q2 2024 | $93.0M |
| Q1 2024 | $98.0M |
| Q4 2023 | $114.0M |
| Q3 2023 | $91.0M |
| Q2 2023 | $80.0M |
| Q1 2023 | $120.0M |
| Q4 2022 | $95.0M |
| Q3 2022 | $94.0M |
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 |
|---|---|---|---|
| SINGULAIR | MONTELUKAST SODIUM | EQ 4MG BASE/PACKET | GRANULE;ORAL |
1 product