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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 020818


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NDA 020818 describes DIOVAN HCT, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the DIOVAN HCT profile page.

The generic ingredient in DIOVAN HCT is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 020818
Tradename:DIOVAN HCT
Applicant:Novartis
Ingredient:hydrochlorothiazide; valsartan
Patents:0
Pharmacology for NDA: 020818
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 020818
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818 NDA Novartis Pharmaceuticals Corporation 0078-0314 0078-0314-34 90 TABLET, FILM COATED in 1 BOTTLE (0078-0314-34)
DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818 NDA Novartis Pharmaceuticals Corporation 0078-0315 0078-0315-34 90 TABLET, FILM COATED in 1 BOTTLE (0078-0315-34)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Mar 6, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;160MG
Approval Date:Mar 6, 1998TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;160MG
Approval Date:Jan 17, 2002TE:ABRLD:Yes

Expired US Patents for NDA 020818

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-001 Mar 6, 1998 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-005 Apr 28, 2006 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-004 Apr 28, 2006 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-005 Apr 28, 2006 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-003 Jan 17, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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