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Last Updated: November 18, 2019

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Details for New Drug Application (NDA): 020111

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NDA 020111 describes CHLORHEXIDINE GLUCONATE, which is a drug marketed by Sage Prods, Bajaj, Hi Tech Pharma, Lyne, Pharm Assoc, Wockhardt Bio Ag, Xttrium, Becton Dickinson, and Kendall Il, and is included in ten NDAs. It is available from thirty 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-three suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.
Summary for 020111
Tradename:CHLORHEXIDINE GLUCONATE
Applicant:Bajaj
Ingredient:chlorhexidine gluconate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020111
Suppliers and Packaging for NDA: 020111
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORHEXIDINE GLUCONATE chlorhexidine gluconate SOLUTION;TOPICAL 020111 NDA Bajaj Medical, LLC 61037-414 61037-414-01 118 mL in 1 BOTTLE, PLASTIC (61037-414-01)
CHLORHEXIDINE GLUCONATE chlorhexidine gluconate SOLUTION;TOPICAL 020111 NDA Bajaj Medical, LLC 61037-414 61037-414-02 236 mL in 1 BOTTLE, PLASTIC (61037-414-02)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength0.75%
Approval Date:Sep 11, 1997TE:RLD:No

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