FdaApplication
NDA 021529
Identifiers
- fda_app_no: NDA021529
Properties
| Property | Value |
|---|---|
| applicant_name | ORGANON USA LLC |
| application_type | NDA |
| approval_date | 2006-07-17 |
Revenue by product
IMPLANON
| Period | Revenue |
|---|---|
| Q2 2026 | $230.0M |
| Q1 2026 | $201.0M |
| Q4 2025 | $210.0M |
| Q3 2025 | $223.0M |
| Q2 2025 | $240.0M |
| Q1 2025 | $248.0M |
| Q4 2024 | $259.0M |
| Q3 2024 | $243.0M |
| Q2 2024 | $242.0M |
| Q1 2024 | $220.0M |
| Q4 2023 | $231.0M |
| Q3 2023 | $220.0M |
| Q2 2023 | $214.0M |
| Q1 2023 | $165.0M |
| Q4 2022 | $239.0M |
| Q3 2022 | $229.0M |
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.
NEXPLANON
| Period | Revenue |
|---|---|
| Q2 2026 | $230.0M |
| Q1 2026 | $201.0M |
| Q4 2025 | $210.0M |
| Q3 2025 | $223.0M |
| Q2 2025 | $240.0M |
| Q1 2025 | $248.0M |
| Q4 2024 | $259.0M |
| Q3 2024 | $243.0M |
| Q2 2024 | $242.0M |
| Q1 2024 | $220.0M |
| Q4 2023 | $231.0M |
| Q3 2023 | $220.0M |
| Q2 2023 | $214.0M |
| Q1 2023 | $165.0M |
| Q4 2022 | $239.0M |
| Q3 2022 | $229.0M |
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 |
|---|---|---|---|
| IMPLANON | ETONOGESTREL | 68MG/IMPLANT | IMPLANT;IMPLANTATION |
| NEXPLANON | ETONOGESTREL | 68MG/IMPLANT | IMPLANT;IMPLANTATION |
2 products