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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 078391

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NDA 078391 describes HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Chartwell Molecular, Hikma Intl Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Jubilant Cadista, Prinston Inc, Quagen, Sciegen Pharms, Sun Pharm Inds Inc, Unichem, Morton Grove, Roxane, Abc Holding, Accord Hlthcare, Actavis Elizabeth, Alra, Ascot, Aurolife Pharma Llc, Barr, Chartwell Rx, Dava Pharms Inc, 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, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, Watson Labs Teva, West Ward, Whiteworth Town Plsn, and Pharmeral, and is included in one hundred and ten NDAs. It is available from forty-one suppliers. Additional details are available on the HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in HYDROCHLOROTHIAZIDE 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 078391

Tradename:	HYDROCHLOROTHIAZIDE
Applicant:	Jubilant Cadista
Ingredient:	hydrochlorothiazide
Patents:	0

Pharmacology for NDA: 078391

Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for 078391

Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 078391

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROCHLOROTHIAZIDE	hydrochlorothiazide	CAPSULE;ORAL	078391	ANDA	Aphena Pharma Solutions - Tennessee, LLC	71610-139	71610-139-60	90 CAPSULE, GELATIN COATED in 1 BOTTLE (71610-139-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	12.5MG
Approval Date:	Feb 11, 2008	TE:	AB	RLD:	No

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