Details for New Drug Application (NDA): 021669

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NDA 021669 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 021669

Tradename:	CHLORHEXIDINE GLUCONATE
Applicant:	Sage Prods
Ingredient:	chlorhexidine gluconate
Patents:	4

Pharmacology for NDA: 021669

Physiological Effect	Decreased Cell Wall Integrity

Medical Subject Heading (MeSH) Categories for 021669

Anti-Infective Agents, Local
Disinfectants
Mouthwashes

Suppliers and Packaging for NDA: 021669

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	CLOTH;TOPICAL	021669	NDA	Sage Products LLC	53462-705	53462-705-20	2 CLOTH in 1 PACKAGE (53462-705-20)
CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	CLOTH;TOPICAL	021669	NDA	Sage Products LLC	53462-705	53462-705-23	6 CLOTH in 1 PACKAGE (53462-705-23)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CLOTH;TOPICAL			Strength	2%
Approval Date:	Apr 25, 2005	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 17, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	DISINFECTION OF PATIENT SKIN PRIOR TO AN INVASIVE PROCEDURE
Patent:	⤷ Sign Up	Patent Expiration:	Apr 25, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Feb 27, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	FOR THE PREPARATION OF SKIN PRIOR TO SURGERY; HELPS REDUCE BACTERIA THAT CAN POTENTIALLY CAUSE SKIN INFECTION

Expired US Patents for NDA 021669

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sage Prods	CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	CLOTH;TOPICAL	021669-001	Apr 25, 2005	⤷ Sign Up	⤷ Sign Up
Sage Prods	CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	CLOTH;TOPICAL	021669-001	Apr 25, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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