Orange Book product · Brand (NDA)
OXYTROL FOR WOMEN
OXYBUTYNIN
Brand (NDA)NDA 202211OTC ABBVIE
At a glance
Jan 25, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 25, 2013
13 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
OXYBUTYNIN
Strength
3.9MG/24HR
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
Not listed
Application
NDA 202211
Product number
001
Marketing status
OTC
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.
