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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 018300

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NDA 018300 describes HIBISTAT, which is a drug marketed by Molnlycke Hlth and is included in one NDA. Additional details are available on the HIBISTAT profile page.

The generic ingredient in HIBISTAT is chlorhexidine gluconate. There are fifty-eight drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.

Summary for 018300

Tradename:	HIBISTAT
Applicant:	Molnlycke Hlth
Ingredient:	chlorhexidine gluconate
Patents:	0

Medical Subject Heading (MeSH) Categories for 018300

Anti-Infective Agents, Local
Disinfectants
Mouthwashes

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SOLUTION;TOPICAL			Strength	0.5%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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