Last Updated: November 9, 2026

Details for New Drug Application (NDA): 088587

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NDA 088587 describes HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Chartwell Molecular, Hikma, Ipca Labs Ltd, Ivax Sub Teva Pharms, Jubilant Cadista, Prinston Inc, Quagen, Sciegen Pharms, Sun Pharm Inds Inc, Unichem, Morton Grove, Roxane, Rubicon Research, Abc Holding, Accord Hlthcare, Actavis Elizabeth, Alra, Ascot, Aurolife Pharma Llc, Barr, Chartwell Rx, Elkins Sinn, Heather, Heritage, Impax Labs, Inwood Labs, Lannett Co Inc, Leading, Mast Mm, Mylan, Oxford Pharms, Pharmobedient, Pvt Form, Solvay, Sun Pharm Industries, Superpharm, Teva, Tp Anda Holdings, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, Watson Labs Teva, West Ward, Whiteworth Town Plsn, and Pharmeral, and is included in one hundred and eleven NDAs. It is available from forty-four suppliers. Additional details are available on the HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in HYDROCHLOROTHIAZIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are four drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.

Summary for 088587

Tradename:	HYDROCHLOROTHIAZIDE
Applicant:	Roxane
Ingredient:	hydrochlorothiazide
Patents:	0

Medical Subject Heading (MeSH) Categories for 088587

Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 2, 1984	TE:		RLD:	Yes

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