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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 009296


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NDA 009296 describes SERPASIL-APRESOLINE, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the SERPASIL-APRESOLINE profile page.

The generic ingredient in SERPASIL-APRESOLINE is hydralazine hydrochloride; reserpine. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; reserpine profile page.
Summary for 009296
Tradename:SERPASIL-APRESOLINE
Applicant:Novartis
Ingredient:hydralazine hydrochloride; reserpine
Patents:0

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG;0.2MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG;0.1MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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