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Generated: November 18, 2018

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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 eight 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. Twenty-four 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021283
Medical Subject Heading (MeSH) Categories for 021283
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:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jul 18, 2001TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Jul 18, 2001TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength320MG
Approval Date:Jul 18, 2001TE:ABRLD:Yes

Expired US Patents for NDA 021283

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis DIOVAN valsartan TABLET;ORAL 021283-002 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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