Orange Book product · Brand (NDA)
BEPREVE
BEPOTASTINE BESILATE
Brand (NDA)NDA 022288TE ATRX BAUSCH AND LOMB INC
At a glance
Sep 08, 2009
Approved
Brand (NDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 08, 2009
17 yr ago
Today
Pharmaceutical detail
Active ingredient
BEPOTASTINE BESILATE
Strength
1.5%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT
Application
NDA 022288
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
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.
