Orange Book product · Generic (ANDA)
IBRUTINIB
IBRUTINIB
Generic (ANDA)ANDA 211344DISCN ZYDUS LIFESCIENCES
At a glance
Mar 31, 2021
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 31, 2021
5 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
IBRUTINIB
Strength
70MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 211344
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of IBRUTINIB
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
