NDC 72000-120
Xenleta 150 mg per 15 mL injection, solution
On the label: Nabriva Therapeutics US, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hovione Limited | Ringaskiddy, Ireland | Makes the active ingredient | No problems foundJan 20, 2023 · 5 inspections |
| Patheon Italia S.p.A. | Monza, Italy | Makes it | Problems found, fixed voluntarilyMay 26, 2023 · 10 inspections |
| Charles River Endotoxin Microbial Detection Europe | Ecully, France | Tests it | No problems foundJun 5, 2024 · 2 inspections |
| Hovione Farmaciencia, S.a. | Loures, Portugal | Tests it | Problems found, fixed voluntarilyOct 24, 2024 · 10 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it | No problems foundNov 21, 2025 · 7 inspections |
Product details
- Generic drug
- Lefamulin: every company that makes it
- Form
- injection, solution
- Strength
- 150 mg per 15 mL
- Approval
- NDA NDA211673
- On the market since
- Sep 9, 2019
- Package NDCs
72000-120-0172000-120-06- Official label
- DailyMed (National Library of Medicine), updated Oct 11, 2024
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