FdaApplication
NDA 022518
Identifiers
- fda_app_no: NDA022518
Properties
| Property | Value |
|---|---|
| applicant_name | ORGANON LLC |
| application_type | NDA |
| approval_date | 2010-06-22 |
Revenue by product
DULERA
| Period | Revenue |
|---|---|
| Q2 2026 | $41.0M* |
| Q1 2026 | $35.0M* |
| Q4 2025 | $35.0M* |
| Q3 2025 | $34.0M* |
| Q2 2025 | $41.0M* |
| Q1 2025 | $43.0M* |
| Q4 2024 | $52.0M* |
| Q3 2024 | $48.0M* |
| Q2 2024 | $47.0M* |
| Q1 2024 | $56.0M* |
| Q4 2023 | $50.0M* |
| Q3 2023 | $49.0M* |
| Q2 2023 | $48.0M* |
| Q1 2023 | $46.0M* |
| Q4 2022 | $53.0M* |
| Q3 2022 | $40.0M* |
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 (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DULERA | FORMOTEROL FUMARATE; MOMETASONE FUROATE | 0.005MG/INH;0.05MG/INH | AEROSOL, METERED;INHALATION |
| DULERA | FORMOTEROL FUMARATE; MOMETASONE FUROATE | 0.005MG/INH;0.1MG/INH | AEROSOL, METERED;INHALATION |
| DULERA | FORMOTEROL FUMARATE; MOMETASONE FUROATE | 0.005MG/INH;0.2MG/INH | AEROSOL, METERED;INHALATION |
3 products