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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020872

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ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE)
60MG
Marketing Status: Over-the-counter
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: ALLEGRA ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020872
Product Number: 007
Approval Date: Jan 24, 2011
Applicant Holder Full Name: CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE)
180MG
Marketing Status: Over-the-counter
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: ALLEGRA ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 180MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020872
Product Number: 010
Approval Date: Jan 24, 2011
Applicant Holder Full Name: CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
ALLEGRA HIVES (FEXOFENADINE HYDROCHLORIDE)
180MG
Marketing Status: Over-the-counter
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: ALLEGRA HIVES
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 180MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020872
Product Number: 009
Approval Date: Jan 24, 2011
Applicant Holder Full Name: CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
ALLEGRA HIVES (FEXOFENADINE HYDROCHLORIDE)
60MG
Marketing Status: Discontinued
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: ALLEGRA HIVES
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020872
Product Number: 008
Approval Date: Jan 24, 2011
Applicant Holder Full Name: CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE
Marketing Status:  Discontinued
Patent and Exclusivity Information
CHILDREN'S ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE)
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ALLEGRA ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020872
Product Number: 005
Approval Date: Jan 24, 2011
Applicant Holder Full Name: CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE
Marketing Status:  Discontinued
Patent and Exclusivity Information
CHILDREN'S ALLEGRA HIVES (FEXOFENADINE HYDROCHLORIDE)
30MG
Marketing Status: Discontinued
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ALLEGRA HIVES
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020872
Product Number: 006
Approval Date: Jan 24, 2011
Applicant Holder Full Name: CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE
Marketing Status:  Discontinued
Patent and Exclusivity Information
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