FdaApplication
NDA 219008
Identifiers
- fda_app_no: NDA219008
Properties
| Property | Value |
|---|---|
| applicant_name | JANSSEN BIOTECH INC |
| application_type | NDA |
| approval_date | 2024-08-19 |
Revenue by product
LAZCLUZE
| Period | Revenue |
|---|---|
| Q2 2026 | $289.0M |
| Q1 2026 | $257.0M |
| Q4 2025 | $216.0M |
| Q3 2025 | $198.0M |
| Q2 2025 | $179.0M |
| Q1 2025 | $141.0M |
| Q4 2024 | $122.0M |
| Q3 2024 | $89.0M |
| Q2 2024 | $69.0M |
| Q1 2024 | $47.0M |
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 |
|---|---|---|---|
| LAZCLUZE | LAZERTINIB MESYLATE | EQ 240MG BASE | TABLET;ORAL |
| LAZCLUZE | LAZERTINIB MESYLATE | EQ 80MG BASE | TABLET;ORAL |
2 products