Orange Book product · Brand (NDA)
BALCOLTRA
ETHINYL ESTRADIOL; LEVONORGESTREL
At a glance
Jan 09, 2018
Approved
Brand (NDA)
Application
AB3
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 09, 2018
8 yr 7 mo ago
Today
Patent 7838042 expires
Listed drug substance patent expiration.
Jun 01, 2027
in 1 yr
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Strength
0.02MG;0.1MG
Dosage form
TABLET
Route
ORAL
TE code
AB3
Application
NDA 208612
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.
- 2020TYBLUMEBrand (NDA)
NDA 209405 · EXELTIS USA INC
- 2020TWIRLABrand (NDA)
NDA 204017 · AGILE
- 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 (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7838042 | Jun 01, 2027 | in 1 yr | SubstanceU-3251 |
