approval · primary record
GANAXOLONE
FDA · NDA · 2025-10-16
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2025-10-16 |
| Approval events | 1 |
| Brand | ZTALMY |
| Sponsor | IMMEDICA PHARMA |
| Route | ORAL |
Approval history
1 action on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2025-10-16 | FDA | NDA | ZTALMY | IMMEDICA PHARMA | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:29:34.525Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:ganaxolone
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Ganaxolone · compound