approval · primary record
NAPROXEN SODIUM
3 approval events · latest 2026-03-10
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-03-10 |
| Approval events | 3 |
| Brand | ALEVE |
| Sponsor | BAYER |
| Route | ORAL |
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 |
|---|---|---|---|---|---|
| 2026-03-10 | FDA | NDA | ALEVE | BAYER | ORAL |
| 2026-01-15 | FDA | NDA | NAPROXEN SODIUM | BIONPHARMA | ORAL |
| 2024-11-21 | FDA | NDA | TREXIMET | AZURITY | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:30:22.170Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:naproxen-sodium
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Naproxen Sodium · compound