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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 Wockhardt, Teva, Becton Dickinson, Hi Tech Pharma, Apotex Inc, Sage Prods, Xttrium, Kendall Il, and Lyne, and is included in nine NDAs. It is available from twenty-four 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-seven 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 NDA: 021669

Tradename:
CHLORHEXIDINE GLUCONATE
Applicant:
Sage Prods
Ingredient:
chlorhexidine gluconate
Patents:5
Therapeutic Class:Dental and Oral Agents
Formulation / Manufacturing:see details

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)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CLOTH;TOPICALStrength2%
Approval Date:Apr 25, 2005TE:RLD:Yes
Patent:7,427,574Patent Expiration:Apr 25, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:7,066,916Patent Expiration:Feb 17, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:DISINFECTION OF PATIENT SKIN PRIOR TO AN INVASIVE PROCEDURE
Patent:7,595,021Patent 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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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 verifification 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.

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