Orange Book product · Generic (ANDA)
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
At a glance
Oct 07, 2025
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 07, 2025
9 mo ago
Today
Pharmaceutical detail
Active ingredient
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength
60MG;120MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 216792
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; PSEUDOEPHEDRINE HYDROCHLORIDE
- 2011ALLEGRA-D 12 HOUR ALLERGY AND CONGESTIONBrand (NDA)
NDA 020786 · CHATTEM SANOFI
- 2011ALLEGRA-D 24 HOUR ALLERGY AND CONGESTIONBrand (NDA)
NDA 021704 · CHATTEM SANOFI
- 2025FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215232 · AUROBINDO PHARMA LTD
- 2022FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215434 · DR REDDYS
- 2017FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 209116 · AUROBINDO PHARMA
- 2015FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090818 · SUN PHARM
- 2014FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 076667 · DR REDDYS
- 2011FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 079043 · DR REDDYS LABS LTD
- 2010FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 076298 · IMPAX PHARMS
- 2005FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 076236 · BARR
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.
