Orange Book product · Generic (ANDA)
NORGESTIMATE AND ETHINYL ESTRADIOL
ETHINYL ESTRADIOL; NORGESTIMATE
At a glance
Nov 12, 2015
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 12, 2015
10 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Strength
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
Dosage form
TABLET
Route
ORAL-28
TE code
Not listed
Application
ANDA 203870
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ETHINYL ESTRADIOL; NORGESTIMATE
- 2002ORTHO TRI-CYCLEN LOBrand (NDA)
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- 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
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.
