approval · primary record
ACETAMINOPHEN
6 approval events · latest 2026-10-02
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-10-02 |
| Approval events | 6 |
| Brand | EXCEDRIN (MIGRAINE RELIEF) |
| Sponsor | HALEON US HOLDINGS |
| 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 |
|---|---|---|---|---|---|
| 2026-10-02 | FDA | NDA | EXCEDRIN (MIGRAINE RELIEF) | HALEON US HOLDINGS | ORAL |
| 2026-07-24 | FDA | NDA | TYLENOL WITH NAPROXEN | KENVUE BRANDS | ORAL |
| 2026-06-18 | FDA | NDA | FIORICET W/ CODEINE | ACTAVIS LABS UT INC | ORAL |
| 2025-05-05 | FDA | NDA | ADVIL DUAL ACTION WITH ACETAMINOPHEN | HALEON US HOLDINGS | ORAL |
| 2024-11-21 | FDA | NDA | COMBOGESIC | AFT PHARMS US | ORAL |
| 2024-10-31 | FDA | NDA | APADAZ | ZEVRA THERAP | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:27:49.485Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:acetaminophen
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Acetaminophen · trial
- Acetaminophen · compound