Orange Book product · Generic (ANDA)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
FEXOFENADINE HYDROCHLORIDE
At a glance
Nov 09, 2017
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 09, 2017
8 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
FEXOFENADINE HYDROCHLORIDE
Strength
30MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
ANDA 208123
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
- 2020FEXOFENADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212971 · L PERRIGO CO
- 2019FEXOFENADINE HYDROCHLORIDE ALLERGYGeneric (ANDA)
ANDA 211075 · GRANULES
- 2018FEXOFENADINE HYDROCHLORIDE ALLERGYGeneric (ANDA)
ANDA 210137 · UNIQUE
- 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.
