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IBRUTINIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TEVA PHARMS USA INC · Approved 2021-03-01

Drug application

FDA Application #
ANDA211350
Application type
Abbreviated New Drug Application (Generic)
Brand name
IBRUTINIB
Generic name
Ibrutinib
Active ingredients
IBRUTINIB
Dosage form
CAPSULE
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
TEVA PHARMS USA INC
First approval
2021-03-01

Source

Authoritative
Drugs@FDA application overview
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