FdaApplication
BLA 021211
Identifiers
- fda_app_no: BLA021211
Properties
| Property | Value |
|---|---|
| applicant_name | Organon USA LLC, a subsidiary of Organon & Co. |
| application_type | BLA |
| approval_date | 2004-03-23 |
Revenue by product
FOLLISTIM AQ
| Period | Revenue |
|---|---|
| Q2 2026 | $59.0M |
| Q1 2026 | $61.0M |
| Q4 2025 | $58.0M |
| Q3 2025 | $64.0M |
| Q2 2025 | $74.0M |
| Q1 2025 | $69.0M |
| Q4 2024 | $66.0M |
| Q3 2024 | $63.0M |
| Q2 2024 | $62.0M |
| Q1 2024 | $46.0M |
| Q4 2023 | $83.0M |
| Q3 2023 | $54.0M |
| Q2 2023 | $70.0M |
| Q1 2023 | $55.0M |
| Q4 2022 | $50.0M |
| Q3 2022 | $60.0M |
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 |
|---|---|---|---|
| FOLLISTIM AQ CARTRIDGE | FOLLITROPIN ALFA/BETA | 300IU/0.36ML | Injection |
| FOLLISTIM AQ CARTRIDGE | FOLLITROPIN ALFA/BETA | 175IU/0.21ML | Injection |
| FOLLISTIM AQ CARTRIDGE | FOLLITROPIN ALFA/BETA | 600IU/0.72ML | Injection |
| FOLLISTIM AQ CARTRIDGE | FOLLITROPIN ALFA/BETA | 900IU/1.08ML | Injection |
4 products