FdaApplication
BLA 103951
Identifiers
- fda_app_no: BLA103951
Properties
| Property | Value |
|---|---|
| applicant_name | Amgen Inc. |
| application_type | BLA |
| approval_date | 2001-09-17 |
Revenue by product
ARANESP
| Period | Revenue |
|---|---|
| Q2 2026 | $352.0M |
| Q1 2026 | $311.0M |
| Q4 2025 | $333.0M |
| Q3 2025 | $357.0M |
| Q2 2025 | $359.0M |
| Q1 2025 | $340.0M |
| Q4 2024 | $308.0M |
| Q3 2024 | $337.0M |
| Q2 2024 | $348.0M |
| Q1 2024 | $349.0M |
| Q4 2023 | $319.0M |
| Q3 2023 | $323.0M |
| Q2 2023 | $365.0M |
| Q1 2023 | $355.0M |
| Q4 2022 | $348.0M |
| Q3 2022 | $358.0M |
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.
ARANESP
| Period | Revenue |
|---|---|
| Q2 2026 | $352.0M |
| Q1 2026 | $311.0M |
| Q4 2025 | $333.0M |
| Q3 2025 | $357.0M |
| Q2 2025 | $359.0M |
| Q1 2025 | $340.0M |
| Q4 2024 | $308.0M |
| Q3 2024 | $337.0M |
| Q2 2024 | $348.0M |
| Q1 2024 | $349.0M |
| Q4 2023 | $319.0M |
| Q3 2023 | $323.0M |
| Q2 2023 | $365.0M |
| Q1 2023 | $355.0M |
| Q4 2022 | $348.0M |
| Q3 2022 | $358.0M |
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 (49)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ARANESP | DARBEPOETIN ALFA | 25MCG/1ML | VIAL;SUBCUTANEOUS |
| ARANESP | DARBEPOETIN ALFA | 25MCG/1ML | VIAL;INTRAVENOUS |
| ARANESP | DARBEPOETIN ALFA | 40MCG/1ML | VIAL;INTRAVENOUS |
| ARANESP | DARBEPOETIN ALFA | 200MCG/1ML | VIAL;SUBCUTANEOUS |
| ARANESP | DARBEPOETIN ALFA | 40MCG/1ML | VIAL;SUBCUTANEOUS |
| ARANESP | DARBEPOETIN ALFA | 200MCG/1ML | VIAL;INTRAVENOUS |
| ARANESP | DARBEPOETIN ALFA | 60MCG/1ML | VIAL;INTRAVENOUS |
| ARANESP | DARBEPOETIN ALFA | 100MCG/1ML | VIAL;SUBCUTANEOUS |
| ARANESP | DARBEPOETIN ALFA | 100MCG/1ML | VIAL;INTRAVENOUS |
| ARANESP | DARBEPOETIN ALFA | 60MCG/1ML | VIAL;SUBCUTANEOUS |
| ARANESP | — | 40MCG/0.4ML | Injection |
| ARANESP | — | 500MCG/1ML | Injection |
| ARANESP | — | 200MCG/0.4ML | Injection |
| ARANESP | — | 150MCG/0.3ML | Injection |
| ARANESP | — | 60MCG/0.3ML | Injection |
| ARANESP | — | 150MCG/0.75ML | Injection |
| ARANESP | — | 60MCG/0.3ML | Injection |
| ARANESP | — | 200MCG/0.4ML | Injection |
| ARANESP | — | 40MCG/0.4ML | Injection |
| ARANESP | — | 100MCG/0.5ML | Injection |
| ARANESP | — | 300MCG/0.6ML | Injection |
| ARANESP | — | 500MCG/1ML | Injection |
| ARANESP | — | 500MCG/1ML | Injection |
| ARANESP | — | 150MCG/0.3ML | Injection |
| ARANESP | — | 25MCG/0.42ML | Injection |
Showing 25 of 49 products