Orange Book product · Brand (NDA)
APHTHASOL
AMLEXANOX
Brand (NDA)NDA 020511DISCN ULURU
At a glance
Dec 17, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 17, 1996
29 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
AMLEXANOX
Strength
5%
Dosage form
PASTE
Route
DENTAL
TE code
Not listed
Application
NDA 020511
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active 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.
