Orange Book product · Brand (NDA)
CHILDREN'S ALLEGRA ALLERGY
FEXOFENADINE HYDROCHLORIDE
At a glance
Jan 24, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 24, 2011
15 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
FEXOFENADINE HYDROCHLORIDE
Strength
30MG
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
Not listed
Application
NDA 021909
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2011CHILDREN'S ALLEGRA ALLERGYBrand (NDA)
NDA 201373 · CHATTEM SANOFI
- 2011ALLEGRA ALLERGYBrand (NDA)
NDA 020872 · CHATTEM SANOFI
- 2006ALLEGRABrand (NDA)
NDA 021963 · CHATTEM SANOFI
- 1996ALLEGRABrand (NDA)
NDA 020625 · CHATTEM SANOFI
- 2025FEXOFENADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219032 · CONTRACT PHARMACAL
- 2023FEXOFENADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213466 · AUROBINDO PHARMA LTD
- 2020FEXOFENADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212971 · L PERRIGO CO
- 2019FEXOFENADINE HYDROCHLORIDE ALLERGYGeneric (ANDA)
ANDA 211075 · GRANULES
- 2018FEXOFENADINE HYDROCHLORIDE ALLERGYGeneric (ANDA)
ANDA 210137 · UNIQUE
- 2017CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYGeneric (ANDA)
ANDA 208123 · TARO
- 2016CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYGeneric (ANDA)
ANDA 204097 · HETERO LABS LTD V
- 2015FEXOFENADINE HYDROCHLORIDE ALLERGYGeneric (ANDA)
ANDA 204507 · SCIEGEN 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.
