approval · primary record
NALOXONE HYDROCHLORIDE
3 approval events · latest 2026-06-16
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-06-16 |
| Approval events | 3 |
| Brand | REXTOVY |
| Sponsor | AMPHASTAR PHARMS INC |
| Route | NASAL |
Approval history
3 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 |
|---|---|---|---|---|---|
| 2026-06-16 | FDA | NDA | REXTOVY | AMPHASTAR PHARMS INC | NASAL |
| 2026-04-09 | FDA | NDA | REZENOPY | SCIENTURE | NASAL |
| 2025-08-25 | FDA | NDA | KLOXXADO | HIKMA | NASAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:31:23.382Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:naloxone-hydrochloride
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Naloxone Hydrochloride · compound