approval · primary record
CETIRIZINE HYDROCHLORIDE
6 approval events · latest 2026-09-28
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-09-28 |
| Approval events | 6 |
| Brand | CHILDREN'S ZYRTEC ALLERGY |
| 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 |
|---|---|---|---|---|---|
| 2026-09-28 | FDA | NDA | CHILDREN'S ZYRTEC ALLERGY | KENVUE BRANDS | ORAL |
| 2026-07-13 | FDA | NDA | CHILDREN'S ZYRTEC HIVES | KENVUE BRANDS | ORAL |
| 2026-07-02 | FDA | NDA | ZYRTEC ALLERGY | KENVUE BRANDS | ORAL |
| 2026-06-11 | FDA | NDA | ZYRTEC HIVES | KENVUE BRANDS | ORAL |
| 2026-01-30 | FDA | NDA | CETIRIZINE HYDROCHLORIDE ALLERGY | BIONPHARMA | ORAL |
| 2025-07-28 | FDA | NDA | QUZYTTIR | ESTEVE | INTRAVENOUS |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:32:08.136Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:cetirizine-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
- Cetirizine Hydrochloride · compound