approval · primary record
SODIUM OXYBATE
2 approval events · latest 2025-11-10
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2025-11-10 |
| Approval events | 2 |
| Brand | LUMRYZ |
| Sponsor | ALKERMES INC |
| Route | ORAL |
Approval history
2 actions 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 |
|---|---|---|---|---|---|
| 2025-11-10 | FDA | NDA | LUMRYZ | ALKERMES INC | ORAL |
| 2025-07-28 | FDA | NDA | XYREM | JAZZ PHARMS | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:29:37.176Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:sodium-oxybate
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Sodium Oxybate · compound