Orange Book product · Generic (ANDA)
BEPOTASTINE BESILATE
BEPOTASTINE BESILATE
Generic (ANDA)ANDA 214588TE ATRX ALEMBIC
At a glance
Apr 05, 2023
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 05, 2023
3 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
BEPOTASTINE BESILATE
Strength
1.5%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT
Application
ANDA 214588
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BEPOTASTINE BESILATE
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.
