approval · primary record
IBRUTINIB
FDA · NDA · 2025-10-21
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2025-10-21 |
| Approval events | 1 |
| Brand | IMBRUVICA |
| Sponsor | PHARMACYCLICS LLC |
| Route | ORAL |
Approval history
1 action 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 |
|---|---|---|---|---|---|
| 2025-10-21 | FDA | NDA | IMBRUVICA | PHARMACYCLICS LLC | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:28:02.823Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:ibrutinib
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