Xenleta
Active substance: lefamulin
TABLET, COATED · LEFAMULIN ACETATE 600 mg/1
United StatesActive
Marketing holder: Meitheal Pharmaceuticals Inc.
Verified 2026-10-09 · openFDA NDC
Analogues in other countries- Source: openFDA NDC
- Countries with the substance registered: 2
Composition
- LEFAMULIN ACETATE · 600 mg/1
Analogues by country
Products with the same active substance registered in other countries.
| Country | Products |
|---|---|
| EU 1 |
|
Import and control
Control by country
- United Statesprescription only
Source: openFDA NDC · record 01a12090-c2e8-74fc-9604-b00eeed8c3b2,01a12097-2429-7605-8f62-d558738fad5f;count=2 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- 71288-037
- Registration status
- Active
- Dispensing
- Prescription only
- Route
- ORAL
Sources
- product · openFDA NDC · 71288-037 · Verified 2026-10-09 · open in source
- registration_status · openFDA NDC · 71288-037 · Verified 2026-10-09 · open in source
- ingredients.0 · openFDA NDC · 71288-037 · Verified 2026-10-09 · open in source