approval · primary record
IBUPROFEN
6 approval events · latest 2026-07-22
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-07-22 |
| Approval events | 6 |
| Brand | CHILDREN'S MOTRIN |
| Sponsor | KENVUE BRANDS |
| Route | ORAL |
Approval history
6 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 |
|---|---|---|---|---|---|
| 2026-07-22 | FDA | NDA | CHILDREN'S MOTRIN | KENVUE BRANDS | ORAL |
| 2026-06-26 | FDA | NDA | CHILDREN'S ADVIL-FLAVORED | HALEON US HOLDINGS | ORAL |
| 2026-05-01 | FDA | NDA | CHILDREN'S ADVIL | HALEON US HOLDINGS | ORAL |
| 2026-01-23 | FDA | NDA | CALDOLOR | APOTEX | INTRAVENOUS |
| 2025-01-08 | FDA | NDA | ADVIL LIQUI-GELS | HALEON US HOLDINGS | ORAL |
| 2024-12-30 | FDA | NDA | ADVIL | HALEON US HOLDINGS | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:28:04.967Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:ibuprofen
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Ibuprofen · compound