FdaApplication
NDA 021057
Identifiers
- fda_app_no: NDA021057
Properties
| Property | Value |
|---|---|
| applicant_name | ORGANON USA LLC A SUB OF ORGANON AND CO |
| application_type | NDA |
| approval_date | 1999-07-29 |
Revenue by product
GANIRELIX ACETATE
| Period | Revenue |
|---|---|
| Q2 2026 | $26.0M |
| Q1 2026 | $26.0M |
| Q4 2025 | $24.0M |
| Q3 2025 | $22.0M |
| Q2 2025 | $27.0M |
| Q1 2025 | $27.0M |
| Q4 2024 | $27.0M |
| Q3 2024 | $26.0M |
| Q2 2024 | $27.0M |
| Q1 2024 | $29.0M |
| Q4 2023 | $22.0M |
| Q3 2023 | $25.0M |
| Q2 2023 | $34.0M |
| Q1 2023 | $30.0M |
| Q4 2022 | $26.0M |
| Q3 2022 | $36.0M |
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 |
|---|---|---|---|
| GANIRELIX ACETATE | GANIRELIX ACETATE | 250MCG/0.5ML | INJECTABLE;INJECTION |
1 product