Orange Book product · Brand (NDA)
ORTHO CYCLEN-28
ETHINYL ESTRADIOL; NORGESTIMATE
At a glance
Dec 29, 1989
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 29, 1989
37 yr ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Strength
0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL-28
TE code
Not listed
Application
NDA 019653
Product number
002
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.
- 2002ORTHO TRI-CYCLEN LOBrand (NDA)
NDA 021241 · JANSSEN PHARMS
- 1992ORTHO TRI-CYCLENBrand (NDA)
NDA 019697 · JANSSEN PHARMS
- 2022TRI-LO-LINYAHGeneric (ANDA)
ANDA 090541 · NOVAST LABS
- 2016TRI-LO-MILIGeneric (ANDA)
ANDA 205762 · AUROBINDO PHARMA
- 2016NORGESTIMATE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 205630 · LUPIN
- 2016MILIGeneric (ANDA)
ANDA 205449 · AUROBINDO PHARMA LTD
- 2016TRI-MILIGeneric (ANDA)
ANDA 205441 · AUROBINDO PHARMA LTD
- 2016NORGESTIMATE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 203873 · NAARI PTE
- 2016NORGESTIMATE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 205588 · LUPIN
- 2016NORGESTIMATE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 204057 · GLENMARK SPECLT
- 2016NORGESTIMATE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 201896 · MYLAN
- 2016NORGESTIMATE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 201897 · XIROMED
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.
