Orange Book product · Generic (ANDA)
AFIRMELLE
ETHINYL ESTRADIOL; LEVONORGESTREL
At a glance
Nov 14, 2016
Approved
Generic (ANDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 14, 2016
9 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Strength
0.02MG;0.1MG
Dosage form
TABLET
Route
ORAL-28
TE code
AB1
Application
ANDA 206886
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; LEVONORGESTREL
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- 2013QUARTETTEBrand (NDA)
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- 2008LOSEASONIQUEBrand (NDA)
NDA 022262 · TEVA BRANDED PHARM
- 2007LYBRELBrand (NDA)
NDA 021864 · WYETH PHARMS INC
- 2006SEASONIQUEBrand (NDA)
NDA 021840 · TEVA BRANDED PHARM
- 2003SEASONALEBrand (NDA)
NDA 021544 · TEVA BRANDED PHARM
- 1998PREVEN EMERGENCY CONTRACEPTIVE KITBrand (NDA)
NDA 020946 · TEVA BRANDED PHARM
- 1998LEVLITEBrand (NDA)
NDA 020860 · BAYER HLTHCARE
- 1997ALESSEBrand (NDA)
NDA 020683 · CADENCE HEALTH
- 1984TRIPHASIL-21Brand (NDA)
NDA 019192 · WYETH PHARMS
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.
