FdaApplication
NDA 020560
Identifiers
- fda_app_no: NDA020560
Properties
| Property | Value |
|---|---|
| applicant_name | ORGANON LLC A SUB OF ORGANON AND CO |
| application_type | NDA |
| approval_date | 1995-09-29 |
Revenue by product
FOSAMAX
| Period | Revenue |
|---|---|
| Q2 2026 | $25.0M |
| Q1 2026 | $29.0M |
| Q4 2025 | $36.0M |
| Q3 2025 | $40.0M |
| Q2 2025 | $34.0M |
| Q1 2025 | $33.0M |
| Q4 2024 | $39.0M |
| Q3 2024 | $38.0M |
| Q2 2024 | $35.0M |
| Q1 2024 | $40.0M |
| Q4 2023 | $36.0M |
| Q3 2023 | $41.0M |
| Q2 2023 | $44.0M |
| Q1 2023 | $38.0M |
| Q4 2022 | $35.0M |
| 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 (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| FOSAMAX | ALENDRONATE SODIUM | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| FOSAMAX | ALENDRONATE SODIUM | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| FOSAMAX | ALENDRONATE SODIUM | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| FOSAMAX | ALENDRONATE SODIUM | EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| FOSAMAX | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL |
5 products