approval · primary record
LORATADINE
3 approval events · latest 2026-09-25
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-09-25 |
| Approval events | 3 |
| Brand | CLARITIN |
| Sponsor | BAYER HEALTHCARE LLC |
| 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 |
|---|---|---|---|---|---|
| 2026-09-25 | FDA | NDA | CLARITIN | BAYER HEALTHCARE LLC | ORAL |
| 2026-05-20 | FDA | NDA | CHILDREN'S CLARITIN | BAYER HEALTHCARE LLC | ORAL |
| 2025-05-09 | FDA | NDA | CLARITIN | BAYER HEALTHCARE LLC | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:28:48.152Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:loratadine
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Loratadine · compound