Details for New Drug Application (NDA): 018538

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NDA 018538 describes LOZOL, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the LOZOL profile page.

The generic ingredient in LOZOL is indapamide. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the indapamide profile page.

Summary for 018538

Tradename:	LOZOL
Applicant:	Sanofi Aventis Us
Ingredient:	indapamide
Patents:	0

Medical Subject Heading (MeSH) Categories for 018538

Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 6, 1983	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 29, 1993	TE:		RLD:	Yes

Expired US Patents for NDA 018538

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	LOZOL	indapamide	TABLET;ORAL	018538-001	Jul 6, 1983	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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