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Last Updated: March 28, 2024

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, Chartwell Rx, Lyne, Pharm Assoc, Xttrium, Becton Dickinson, and Kendall Il, and is included in ten NDAs. It is available from twenty-seven 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-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:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 021669
Physiological EffectDecreased Cell Wall Integrity
Medical Subject Heading (MeSH) Categories for 021669
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:OTCDosage:CLOTH;TOPICALStrength2%
Approval Date:Apr 25, 2005TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 17, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:DISINFECTION OF PATIENT SKIN PRIOR TO AN INVASIVE PROCEDURE
Patent:⤷  Try a TrialPatent Expiration:Apr 25, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Feb 27, 2025Product Flag?YSubstance 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

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
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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