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IBRUTINIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALVOGEN PINE BROOK · Approved 2021-04-09

Drug application

FDA Application #
ANDA212763
Application type
Abbreviated New Drug Application (Generic)
Brand name
IBRUTINIB
Generic name
Ibrutinib
Active ingredients
IBRUTINIB
Dosage form
TABLET
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
ALVOGEN PINE BROOK
First approval
2021-04-09

Source

Authoritative
Drugs@FDA application overview
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