ZTALMY
Active substance: ganaxolone
SUSPENSION · GANAXOLONE 50 mg/mL
United StatesActive
Marketing holder: Immedica Pharma US Inc
Verified 2026-10-09 · openFDA NDC
Analogues in other countries- Source: openFDA NDC
- Countries with the substance registered: 2
Composition
- GANAXOLONE · 50 mg/mL
Analogues by country
Products with the same active substance registered in other countries.
| Country | Products |
|---|---|
| EU 1 |
|
Import and control
Control by country
- United StatescontrolledSchedule: CV
Source: openFDA NDC · record 01a1208c-d9b7-76f8-86cb-34d73f3ea185;count=1 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- 81583-100
- Registration status
- Active
- Dispensing
- Prescription only
- Control marker
- CV
- Route
- ORAL
Sources
- product · openFDA NDC · 81583-100 · Verified 2026-10-09 · open in source
- registration_status · openFDA NDC · 81583-100 · Verified 2026-10-09 · open in source
- ingredients.0 · openFDA NDC · 81583-100 · Verified 2026-10-09 · open in source