Orange Book product · Brand (NDA)
ORTHO EVRA
ETHINYL ESTRADIOL; NORELGESTROMIN
At a glance
Nov 20, 2001
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 20, 2001
24 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORELGESTROMIN
Strength
0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
Not listed
Application
NDA 021180
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.
