Orange Book product · Brand (NDA)
ORTHO TRI-CYCLEN
ETHINYL ESTRADIOL; NORGESTIMATE
At a glance
Jul 03, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 03, 1992
34 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Strength
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 019697
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.
- 2002ORTHO TRI-CYCLEN LOBrand (NDA)
NDA 021241 · JANSSEN PHARMS
- 1989ORTHO CYCLEN-21Brand (NDA)
NDA 019653 · 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.
