Details for New Drug Application (NDA): 021669

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NDA 021669 describes CHLORHEXIDINE GLUCONATE, which is a drug marketed by Sage Prods, Akorn, Bajaj, Lyne, Pharm Assoc, Wockhardt Bio Ag, Xttrium, Becton Dickinson, and Kendall Il, and is included in ten NDAs. It is available from twenty-seven suppliers. There are five 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-three 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:	5
Formulation / Manufacturing:	see details

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:	⤷ Try a Trial	Patent Expiration:	Feb 17, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	DISINFECTION OF PATIENT SKIN PRIOR TO AN INVASIVE PROCEDURE
Patent:	⤷ Try a Trial	Patent Expiration:	Apr 25, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	May 12, 2023	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	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.