Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076447

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FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE)
30MG
Marketing Status: Prescription
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: FEXOFENADINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076447
Product Number: 001
Approval Date: Sep 1, 2005
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE)
60MG
Marketing Status: Prescription
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: FEXOFENADINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076447
Product Number: 002
Approval Date: Sep 1, 2005
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE)
180MG
Marketing Status: Prescription
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: FEXOFENADINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 180MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076447
Product Number: 003
Approval Date: Sep 1, 2005
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (FEXOFENADINE HYDROCHLORIDE)
30MG
Marketing Status: Over-the-counter
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076447
Product Number: 004
Approval Date: Apr 13, 2011
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES (FEXOFENADINE HYDROCHLORIDE)
30MG
Marketing Status: Over-the-counter
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076447
Product Number: 005
Approval Date: Apr 13, 2011
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
FEXOFENADINE HYDROCHLORIDE ALLERGY (FEXOFENADINE HYDROCHLORIDE)
60MG
Marketing Status: Over-the-counter
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: FEXOFENADINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076447
Product Number: 006
Approval Date: Apr 13, 2011
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
FEXOFENADINE HYDROCHLORIDE ALLERGY (FEXOFENADINE HYDROCHLORIDE)
180MG
Marketing Status: Over-the-counter
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: FEXOFENADINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 180MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076447
Product Number: 008
Approval Date: Apr 13, 2011
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
FEXOFENADINE HYDROCHLORIDE HIVES (FEXOFENADINE HYDROCHLORIDE)
60MG
Marketing Status: Over-the-counter
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: FEXOFENADINE HYDROCHLORIDE HIVES
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076447
Product Number: 007
Approval Date: Apr 13, 2011
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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