Orange Book product · Generic (ANDA)
XULANE
ETHINYL ESTRADIOL; NORELGESTROMIN
Generic (ANDA)ANDA 200910TE ABRX MYLAN TECHNOLOGIES
At a glance
Apr 16, 2014
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 16, 2014
12 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORELGESTROMIN
Strength
0.035MG/24HR;0.15MG/24HR
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
AB
Application
ANDA 200910
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of ETHINYL ESTRADIOL; NORELGESTROMIN
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.
