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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 083177

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NDA 083177 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, Norvium Bioscience, Prinston Inc, Sciegen Pharms Inc, 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, Pvt Form, Solvay, Sun Pharm Industries, Superpharm, Teva, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, Watson Labs Teva, West Ward, Whiteworth Town Plsn, Alkem Labs Ltd, 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 twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.

Summary for 083177

Tradename:	HYDROCHLOROTHIAZIDE
Applicant:	Ivax Sub Teva Pharms
Ingredient:	hydrochlorothiazide
Patents:	0

Pharmacology for NDA: 083177

Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for 083177

Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 083177

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROCHLOROTHIAZIDE	hydrochlorothiazide	TABLET;ORAL	083177	ANDA	Teva Pharmaceuticals USA, Inc.	0172-2083	0172-2083-60	100 TABLET in 1 BOTTLE (0172-2083-60)
HYDROCHLOROTHIAZIDE	hydrochlorothiazide	TABLET;ORAL	083177	ANDA	Teva Pharmaceuticals USA, Inc.	0172-2083	0172-2083-80	1000 TABLET in 1 BOTTLE (0172-2083-80)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Sep 19, 2024	TE:	AB	RLD:	No

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