← FDA Drug Approvals (Drugs@FDA)
IMBRUVICA
NDA · New Drug Application · Sponsor: PHARMACYCLICS LLC · Approved 2013-11-13
Drug application
- FDA Application #
NDA205552- Application type
- New Drug Application
- Brand name
- IMBRUVICA
- Generic name
- IBRUTINIB
- Active ingredients
- IBRUTINIB
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PHARMACYCLICS LLC
- Manufacturer
- Pharmacyclics LLC
- First approval
- 2013-11-13
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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