Orange Book product · Generic (ANDA)
FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE
At a glance
Feb 24, 2020
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 24, 2020
6 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
FEXOFENADINE HYDROCHLORIDE
Strength
60MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 212971
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FEXOFENADINE HYDROCHLORIDE
- 2011CHILDREN'S ALLEGRA ALLERGYBrand (NDA)
NDA 201373 · CHATTEM SANOFI
- 2011CHILDREN'S ALLEGRA ALLERGYBrand (NDA)
NDA 021909 · 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
- 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.
