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Generated: April 26, 2019

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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, Hi Tech Pharma, Lyne, Teva, Wockhardt Bio Ag, Xttrium, Becton Dickinson, and Kendall Il, and is included in nine NDAs. It is available from thirty-five 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. Sixty-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:5
Formulation / Manufacturing:see details
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, Inc. 53462-007 53462-007-27 1 KIT in 1 KIT (53462-007-27) * 6 CLOTH in 1 PACKAGE (53462-705-23) * 4 mL in 1 BOTTLE (17518-060-04) * 15 mL in 1 BOTTLE (48878-0620-4)
CHLORHEXIDINE GLUCONATE chlorhexidine gluconate CLOTH;TOPICAL 021669 NDA Sage Products, Inc. 53462-008 53462-008-28 1 KIT in 1 KIT (53462-008-28) * 6 CLOTH in 1 PACKAGE (53462-705-23) * 1 BOTTLE in 1 POUCH > 4 mL in 1 BOTTLE (17518-060-04)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CLOTH;TOPICALStrength2%
Approval Date:Apr 25, 2005TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 17, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:DISINFECTION OF PATIENT SKIN PRIOR TO AN INVASIVE PROCEDURE
Patent:➤ Sign UpPatent Expiration:Apr 25, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:May 12, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR THE PREPARATION OF SKIN PRIOR TO SURGERY; HELPS REDUCE BACTERIA THAT CAN POTENTIALLY CAUSE SKIN INFECTION

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