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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020758

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AVALIDE (HYDROCHLOROTHIAZIDE; IRBESARTAN)
12.5MG;150MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; IRBESARTAN
Proprietary Name: AVALIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;150MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020758
Product Number: 002
Approval Date: Sep 30, 1997
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
AVALIDE (HYDROCHLOROTHIAZIDE; IRBESARTAN)
12.5MG;300MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; IRBESARTAN
Proprietary Name: AVALIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020758
Product Number: 003
Approval Date: Aug 31, 1998
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
AVALIDE (HYDROCHLOROTHIAZIDE; IRBESARTAN)
12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROCHLOROTHIAZIDE; IRBESARTAN
Proprietary Name: AVALIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020758
Product Number: 001
Approval Date: Sep 30, 1997
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
AVALIDE (HYDROCHLOROTHIAZIDE; IRBESARTAN)
25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROCHLOROTHIAZIDE; IRBESARTAN
Proprietary Name: AVALIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020758
Product Number: 004
Approval Date: Mar 15, 2005
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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