Last Updated: September 28, 2026

Details for New Drug Application (NDA): 086028

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NDA 086028 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-three NDAs. Additional details are available on the CHLOROTHIAZIDE profile page.

The generic ingredient in CHLOROTHIAZIDE is chlorothiazide sodium. There are three 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 086028

Tradename:	CHLOROTHIAZIDE
Applicant:	Hikma Intl Pharms
Ingredient:	chlorothiazide
Patents:	0

Medical Subject Heading (MeSH) Categories for 086028

Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jul 14, 1982	TE:		RLD:	No

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