Orange Book product · Generic (ANDA)
BOSUTINIB MONOHYDRATE
BOSUTINIB MONOHYDRATE
Generic (ANDA)ANDA 209543TE ABRX ALEMBIC
At a glance
May 23, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 23, 2025
1 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
BOSUTINIB MONOHYDRATE
Strength
EQ 100MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 209543
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BOSUTINIB MONOHYDRATE
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.
