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. Nineteen 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 Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased 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:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;80MG
Approval Date:	Mar 6, 1998	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;160MG
Approval Date:	Mar 6, 1998	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;160MG
Approval Date:	Jan 17, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020818

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-005	Apr 28, 2006	⤷ Sign Up	⤷ Sign Up
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-002	Mar 6, 1998	⤷ Sign Up	⤷ Sign Up
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-003	Jan 17, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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