Orange Book product · Generic (ANDA)
TRI-SPRINTEC
ETHINYL ESTRADIOL; NORGESTIMATE
At a glance
Dec 29, 2003
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 29, 2003
22 yr 10 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
AB
Application
ANDA 075808
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; NORGESTIMATE
- 2002ORTHO TRI-CYCLEN LOBrand (NDA)
NDA 021241 · JANSSEN PHARMS
- 1992ORTHO TRI-CYCLENBrand (NDA)
NDA 019697 · 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
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.
