Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076191
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Prescription AB No No
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Prescription AB No No
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/31/2005 ORIG-1 Approval

Label is not available on this site.

FEXOFENADINE HYDROCHLORIDE

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 076191 BARR
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 076447 TEVA

TABLET;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 076191 BARR
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 077081 MYLAN
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 076447 TEVA

TABLET;ORAL; 180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Prescription No AB 076191 BARR
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Prescription No AB 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Prescription No AB 077081 MYLAN
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Prescription No AB 076447 TEVA

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