Orange Book product · Generic (ANDA)
TURQOZ
ETHINYL ESTRADIOL; NORGESTREL
At a glance
Jul 31, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 31, 2023
2 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORGESTREL
Strength
0.03MG;0.3MG
Dosage form
TABLET
Route
ORAL-28
TE code
AB
Application
ANDA 202980
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ETHINYL ESTRADIOL; NORGESTREL
- —LO/OVRALBrand (NDA)
NDA 017612 · CADENCE HEALTH
- —OVRALBrand (NDA)
NDA 016672 · WYETH PHARMS
- —LO/OVRAL-28Brand (NDA)
NDA 017802 · WYETH PHARMS
- —OVRAL-28Brand (NDA)
NDA 016806 · WYETH PHARMS
- 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.
