Orange Book product · Generic (ANDA)
BEPOTASTINE BESILATE
BEPOTASTINE BESILATE
Generic (ANDA)ANDA 217770TE ATRX SOMERSET THERAPS LLC
At a glance
Aug 14, 2024
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 14, 2024
1 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
BEPOTASTINE BESILATE
Strength
1.5%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT
Application
ANDA 217770
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.
