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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 085569

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NDA 085569 describes CHLOROTHIAZIDE, which is a drug marketed by Abc Holding, Hikma Intl Pharms, Lederle, Pharmobedient, Sandoz, Watson Labs, Hikma, Am Regent, Fresenius Kabi Usa, Gland, Rk Pharma, Sagent Pharms Inc, and Sun Pharm, and is included in twenty-four NDAs. Additional details are available on the CHLOROTHIAZIDE profile page.

The generic ingredient in CHLOROTHIAZIDE is chlorothiazide sodium. There are forty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the chlorothiazide sodium profile page.

Summary for 085569

Tradename:	CHLOROTHIAZIDE
Applicant:	Abc Holding
Ingredient:	chlorothiazide
Patents:	0

Medical Subject Heading (MeSH) Categories for 085569

Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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