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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 085317

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NDA 085317 describes HYDROCHLOROTHIAZIDE W/ RESERPINE, which is a drug marketed by Ivax Sub Teva Pharms, Pharmeral, Roxane, and Watson Labs, and is included in fourteen NDAs. Additional details are available on the HYDROCHLOROTHIAZIDE W/ RESERPINE profile page.

The generic ingredient in HYDROCHLOROTHIAZIDE W/ RESERPINE 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 085317

Tradename:	HYDROCHLOROTHIAZIDE W/ RESERPINE
Applicant:	Watson Labs
Ingredient:	hydrochlorothiazide; reserpine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;0.125MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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