Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021283

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DIOVAN (VALSARTAN)
40MG
Marketing Status: Prescription

Active Ingredient: VALSARTAN
Proprietary Name: DIOVAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021283
Product Number: 004
Approval Date: Aug 14, 2002
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

DIOVAN (VALSARTAN)
80MG
Marketing Status: Prescription

Active Ingredient: VALSARTAN
Proprietary Name: DIOVAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021283
Product Number: 001
Approval Date: Jul 18, 2001
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

DIOVAN (VALSARTAN)
160MG
Marketing Status: Prescription

Active Ingredient: VALSARTAN
Proprietary Name: DIOVAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 160MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021283
Product Number: 002
Approval Date: Jul 18, 2001
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

DIOVAN (VALSARTAN)
320MG
Marketing Status: Prescription

Active Ingredient: VALSARTAN
Proprietary Name: DIOVAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 320MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021283
Product Number: 003
Approval Date: Jul 18, 2001
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information