Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Janssen Cilag SpA | Borgo San Michele, Italy | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilySep 27, 2024 · 6 inspections |
| Janssen Pharmaceutica NV | Geel, Belgium | Makes it, makes the active ingredient and tests it | Problems found, fixed voluntarilyMar 26, 2024 · 7 inspections |
| Yuhan Chemical Inc. | Ansan-si, South Korea | Makes the active ingredient | Problems found, fixed voluntarilyFeb 28, 2025 · 6 inspections |
| Johnson & Johnson Private Limited | Mumbai, India | Tests it | No problems foundApr 30, 2025 · 4 inspections |
Product details
- Generic drug
- Lazertinib: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 80 mg
- Approval
- NDA NDA219008
- On the market since
- Aug 20, 2024
- Package NDCs
57894-080-6057894-080-90- Official label
- DailyMed (National Library of Medicine), updated May 5, 2026
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