approval · primary record
ROFLUMILAST
2 approval events · latest 2026-06-29
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-06-29 |
| Approval events | 2 |
| Brand | ZORYVE |
| Sponsor | ARCUTIS |
| Route | TOPICAL |
Approval history
2 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 |
|---|---|---|---|---|---|
| 2026-06-29 | FDA | NDA | ZORYVE | ARCUTIS | TOPICAL |
| 2025-05-22 | FDA | NDA | ZORYVE | ARCUTIS | TOPICAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:28:37.736Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:roflumilast
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Roflumilast · compound