Details for New Drug Application (NDA): 021283

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NDA 021283 describes DIOVAN, which is a drug marketed by Novartis and is included in three NDAs. It is available from two suppliers. Additional details are available on the DIOVAN profile page.

The generic ingredient in DIOVAN 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 021283

Tradename:	DIOVAN
Applicant:	Novartis
Ingredient:	valsartan
Patents:	0

Pharmacology for NDA: 021283

Mechanism of Action	Angiotensin 2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 021283

Angiotensin II Type 1 Receptor Blockers
Antihypertensive Agents

Suppliers and Packaging for NDA: 021283

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIOVAN	valsartan	TABLET;ORAL	021283	NDA	Novartis Pharmaceuticals Corporation	0078-0358	0078-0358-34	90 TABLET in 1 BOTTLE (0078-0358-34)
DIOVAN	valsartan	TABLET;ORAL	021283	NDA	Novartis Pharmaceuticals Corporation	0078-0359	0078-0359-34	90 TABLET in 1 BOTTLE (0078-0359-34)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Jul 18, 2001	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 19, 2024
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	160MG
Approval Date:	Jul 18, 2001	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 19, 2024
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	320MG
Approval Date:	Jul 18, 2001	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021283

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-003	Jul 18, 2001	⤷ Sign Up	⤷ Sign Up
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-004	Aug 14, 2002	⤷ Sign Up	⤷ Sign Up
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-001	Jul 18, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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