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ACTIVE SUBSTANCE / INN

FEXOFENADINE HYDROCHLORIDE

Brand name(s): FEXOFENADINE HYDROCHLORIDE HIVES, CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HCL; PSEUDOEPHEDRINE HCL, FEXOFENADINE HYDROCHLORIDE, CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
FDA LISTED
OVER-THE-COUNTER
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA076707
ANDA204097
ACTIVE SUBSTANCE
Fexofenadine Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
SUN PHARM INDS, SANDOZ, AUROBINDO PHARMA LTD
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
FEXOFENADINE HCL; PSEUDOEPHEDRINE HCLANDA076538MYLANNone (Tentative Approval)
FEXOFENADINE HYDROCHLORIDEANDA076707SANDOZNone (Tentative Approval)
FEXOFENADINE HYDROCHLORIDE ALLERGYANDA091567SUN PHARM INDSOver-the-counter
FEXOFENADINE HYDROCHLORIDE ALLERGYANDA091567SUN PHARM INDSDiscontinued
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYANDA091567SUN PHARM INDSDiscontinued
FEXOFENADINE HYDROCHLORIDE HIVESANDA091567SUN PHARM INDSOver-the-counter
FEXOFENADINE HYDROCHLORIDE HIVESANDA091567SUN PHARM INDSDiscontinued
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESANDA091567SUN PHARM INDSDiscontinued
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYANDA204097HETERO LABS LTD VOver-the-counter
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEANDA215232AUROBINDO PHARMA LTDOver-the-counter

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