Orange Book product · Brand (NDA)
ULESFIA
BENZYL ALCOHOL
At a glance
Apr 09, 2009
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 09, 2009
17 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
BENZYL ALCOHOL
Strength
5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
LOTION
Route
TOPICAL
TE code
Not listed
Application
NDA 022129
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
