Orange Book product · Brand (NDA)
TYBLUME
ETHINYL ESTRADIOL; LEVONORGESTREL
At a glance
Mar 30, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 30, 2020
6 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Strength
0.02MG;0.1MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 209405
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2020TWIRLABrand (NDA)
NDA 204017 · AGILE
- 2018BALCOLTRABrand (NDA)
NDA 208612 · AVION PHARMS
- 2013QUARTETTEBrand (NDA)
NDA 204061 · TEVA BRANDED PHARM
- 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
- 1982NORDETTE-21Brand (NDA)
NDA 018668 · TEVA BRANDED PHARM
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.
