Orange Book product · Generic (ANDA)
NORGESTIMATE AND ETHINYL ESTRADIOL
ETHINYL ESTRADIOL; NORGESTIMATE
At a glance
Oct 27, 2016
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 27, 2016
9 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Strength
0.035MG;0.25MG
Dosage form
TABLET
Route
ORAL-28
TE code
AB
Application
ANDA 205630
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
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- 2016TRI-MILIGeneric (ANDA)
ANDA 205441 · AUROBINDO PHARMA LTD
- 2016NORGESTIMATE AND ETHINYL ESTRADIOLGeneric (ANDA)
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ANDA 204057 · GLENMARK SPECLT
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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.

