Orange Book product · Brand (NDA)
GELNIQUE 3%
OXYBUTYNIN
Brand (NDA)NDA 202513DISCN ALLERGAN
At a glance
Dec 07, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 07, 2011
14 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
OXYBUTYNIN
Strength
3%
Dosage form
GEL, METERED
Route
TRANSDERMAL
TE code
Not listed
Application
NDA 202513
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.
