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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020818

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DIOVAN HCT (HYDROCHLOROTHIAZIDE; VALSARTAN)
12.5MG;80MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: DIOVAN HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020818
Product Number: 001
Approval Date: Mar 6, 1998
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
DIOVAN HCT (HYDROCHLOROTHIAZIDE; VALSARTAN)
12.5MG;160MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: DIOVAN HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;160MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020818
Product Number: 002
Approval Date: Mar 6, 1998
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
DIOVAN HCT (HYDROCHLOROTHIAZIDE; VALSARTAN)
12.5MG;320MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: DIOVAN HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;320MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020818
Product Number: 004
Approval Date: Apr 28, 2006
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
DIOVAN HCT (HYDROCHLOROTHIAZIDE; VALSARTAN)
25MG;160MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: DIOVAN HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;160MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020818
Product Number: 003
Approval Date: Jan 17, 2002
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
DIOVAN HCT (HYDROCHLOROTHIAZIDE; VALSARTAN)
25MG;320MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: DIOVAN HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;320MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020818
Product Number: 005
Approval Date: Apr 28, 2006
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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