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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
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