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Details for New Drug Application (NDA): 020665

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NDA 020665 describes DIOVAN, which is a drug marketed by Novartis and is included in three NDAs. It is available from twelve suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the DIOVAN profile page.

The generic ingredient in DIOVAN is hydrochlorothiazide; valsartan. There are thirty-one drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.

Summary for NDA: 020665

Therapeutic Class:Cardiovascular Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength80MG
Approval Date:Dec 23, 1996TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength160MG
Approval Date:Dec 23, 1996TE:RLD:No

Expired Orange Book Patents for NDA: 020665

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
CAPSULE;ORAL020665-001Dec 23, 19965,399,578*PED► subscribe
CAPSULE;ORAL020665-002Dec 23, 19965,399,578*PED► subscribe
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