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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 012193

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NDA 012193 describes SER-AP-ES, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the SER-AP-ES profile page.

The generic ingredient in SER-AP-ES is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.

Summary for 012193

Tradename:	SER-AP-ES
Applicant:	Novartis
Ingredient:	hydralazine hydrochloride; hydrochlorothiazide; reserpine
Patents:	0

Profile for product number 005

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;15MG;0.1MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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