← FDA Drug Approvals (Drugs@FDA)
IMBRUVICA
NDA · New Drug Application · Sponsor: PHARMACYCLICS LLC · Approved 2022-08-24
Drug application
- FDA Application #
NDA217003
- Application type
- New Drug Application
- Brand name
- IMBRUVICA
- Generic name
- IBRUTINIB
- Active ingredients
- IBRUTINIB
- Dosage form
- SUSPENSION
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PHARMACYCLICS LLC
- Manufacturer
- Pharmacyclics LLC
- First approval
- 2022-08-24
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown