Details for New Drug Application (NDA): 020111

NDA 020111 describes CHLORHEXIDINE GLUCONATE, which is a drug marketed by Sage Prods, Bajaj, Chartwell Rx, Lyne, Pharm Assoc, Sciegen Pharms Inc, Xttrium, Becton Dickinson, and Kendall Il, and is included in ten NDAs. It is available from twenty-nine suppliers. There are four patents protecting this drug. Additional details are available on the CHLORHEXIDINE GLUCONATE profile page.

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

Summary for 020111

Tradename:	CHLORHEXIDINE GLUCONATE
Applicant:	Bajaj
Ingredient:	chlorhexidine gluconate
Patents:	0

Pharmacology for NDA: 020111

Physiological Effect

Decreased Cell Wall Integrity

Medical Subject Heading (MeSH) Categories for 020111

Anti-Infective Agents, Local

Disinfectants

Mouthwashes

Suppliers and Packaging for NDA: 020111

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	SOLUTION;TOPICAL	020111	NDA	Bajaj Medical, LLC	61037-414	61037-414-01	118 mL in 1 BOTTLE, PLASTIC (61037-414-01)
CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	SOLUTION;TOPICAL	020111	NDA	Bajaj Medical, LLC	61037-414	61037-414-02	236 mL in 1 BOTTLE, PLASTIC (61037-414-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SOLUTION;TOPICAL			Strength	0.75%
Approval Date:	Sep 11, 1997	TE:		RLD:	No

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