Orange Book product · Brand (NDA)
OVRAL
ETHINYL ESTRADIOL; NORGESTREL
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORGESTREL
Strength
0.05MG;0.5MG
Dosage form
TABLET
Route
ORAL-21
TE code
Not listed
Application
NDA 016672
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.
- —LO/OVRALBrand (NDA)
NDA 017612 · CADENCE HEALTH
- —LO/OVRAL-28Brand (NDA)
NDA 017802 · WYETH PHARMS
- —OVRAL-28Brand (NDA)
NDA 016806 · WYETH PHARMS
- 2023TURQOZGeneric (ANDA)
ANDA 202980 · LUPIN
- 2017NORGESTREL AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 202875 · MYLAN LABS LTD
- 2016NORGESTREL AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 201828 · MYLAN LABS LTD
- 2012ELINESTGeneric (ANDA)
ANDA 091105 · NOVAST LABS LTD
- 2001CRYSELLEGeneric (ANDA)
ANDA 075840 · DURAMED PHARMS BARR
- 1999OGESTREL 0.5/50-21Generic (ANDA)
ANDA 075406 · WATSON LABS
- 1999LOW-OGESTREL-21Generic (ANDA)
ANDA 075288 · DR REDDYS LABS SA
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.
