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CHLORHEXIDINE

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

FDA Approval Activities for this Drug…

Avagard (Chlorhexidine Gluconate Solution & Ethyl Alcohol) 3M Health Care NDA 21-074 ChloraPrep One-Step Sepp Applicators (2% chlorhexidine gluconate solution), Beckloff Associates, NDA 21-555 10/7/02 10/11/02 10/8/02 ChloraPrep One-Step Frepp Applicators, Beckloff Associates NDA 20-832/S2 4/26/02 5/2/02 4/29/02 ChloraPrep (Chlorhexidine Gluconate 2% (w/v) and Isopropyl Alcohol 70% (v/v)) One-Step, or OTC Medi-Flex Hospital Products, NDA 20-832 7/14/00 7/24/00 2/4/03 ChloraPrep Indications: Patient Preoperative Skin Preparation Chlorhexidine Gluconate Rinse,0.12%, Novex Pharma ANDA 75-561 11/14/00 11/17/00 Chlorhexidine Gluconate Solution, Medi-Flex NDA 20-832/S4 8/20/03 8/28/03 8/28/03 Chlorhexidine Gluconate Topical Scrub,4%, OTC Becton Dickinson Surgical System ANDA 73-416 PerioChip (Chlorhexidine gluconate), 2.5 mg Dexcel Pharma Technologies, LTD. NDA 20-774/S3 12/15/02 1/29/03 12/16/02 PerioChip (Chlorhexidine gluconate), 2.5 mg Target Research Associates NDA 20-774 5/15/98 5/15/98 5/15/98 1/7/99 PerioChip Indications: PerioChip is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. PerioChip may be used as a part of a periodontal maintenance program, which includes good oral hygiene and scaling and root planing. Pre-Scrub II (4% chlorhexidine gluconate) Solution, Biomed Systems, NDA 19-822/S-006 CHLORHEXIDINE GLUCONATE Solution; Dental 0.12% CHLORHEXIDINE GLUCONATE ALPHARMA 073695 AT CHLORHEXIDINE GLUCONATE Solution; Dental 0.12% PERIOGARD COLGATE 074356 AT CHLORHEXIDINE GLUCONATE Solution; Dental 0.12% CHLORHEXIDINE GLUCONATE HI TECH 075561 AT CHLORHEXIDINE GLUCONATE Solution; Dental 0.12% CHLORHEXIDINE GLUCONATE Novex 074522 AT CHLORHEXIDINE GLUCONATE Solution; Dental 0.12% CHLORHEXIDINE GLUCONATE Teva 019028 AT CHLORHEXIDINE GLUCONATE Solution; Dental 0.12% PERIDEX ZILA 020774 CHLORHEXIDINE GLUCONATE Tablet; Dental 2.5MG PERIOCHIP DEXCEL Chlorhexidine Gluconate Solution, XTTRIUM Habistat (0.5% Chlorhexidine Gluconate) Solution & Towelettes, SSL Americas, Inc. PerioChip (Chlorhexidine gluconate), Dexcel Pharma Chlorhexidine Gluconate Oral Rinse, Morton Grove Pharmaceuticals ChloraPrep One -Step (2% chlorhexidine gluconate solution), Beckloff Associates ChloraPrep One -Step 10.5- mL Applicators (2% chlorhexidine gluconate solution), Beckloff Associates, Labeling Revision | Bactoshield CHG 2% (2% chorhexidine gluconate) solution, Xttrium Labs, Package Change | Endure 420 Cida-Stat (2% and 4% chlorhexidine gluconate) solution, Ecolab, Inc., Package Change | Chlorhexidine Gluconate Cloth, Sage Products, Approval | ChloraPrep w/Tint, Medi-Flex, Formulation Revision | Exidine (4% chlorhexidine gluconate solution), Xttrium Labs, Labeling Revision | ChloraPrep Single Swabstick, Medi-Flex, Package Change | Chlorhexidine Gluconate Oral Rinse, John O. Butler Co., Approval | 2% chlorhexidine gluconate cloth, Sage Products, Labeling Revision | ChloraPrep topical solution, Medi-Flex, Package Change | Endure 420 & 400 solution, Ecolab, Package Change | Chlorhexidine 2% gluconate cloth, Sage Products, Labeling Revision | ChloraPrep (chlorhexidine gluconate (w/v) topical solution), Medi-Flex, Inc., Labeling Revision | ChloraPrep (chlorhexidine gluconate (w/v) topical solution), Medi-Flex Inc., Package Change | ChloraPrep (chlorhexidine gluconate (w/v) topical solution), Medi-Flex, Labeling Revision | ChloraPrep (chlorhexidine gluconate (w/v)) topical solution, Medi-Flex Inc., Labeling Revision | Chlorascrub Swab, Nice Pak Products, Package Change | ChloraPrep (2% chlorhexidine gluconate (w/v) topical solution), Enturia Inc., Labeling Revision | ChloraPrep (chlorhexidine gluconate) Topical Solution, Enturia Inc., Control Supplement | Chlorascrub Swabstick and Maxi Swabstick (chlorhexidine gluconate w/ isopropyl alcohol), PDI Healthcare, Package Change | ChloraPrep (chlorhexidine gluconate and isopropyl alcohol) Sponge, Enturia, Inc., Formulation Revision | ChloraPrep (chlorhexidine gluconate and isopropyl alcohol) Sponge, Cardinal Health, Package Change | Exidine (chlorhexidine gluconate) Topical Solution, Xttrium Laboratories, Inc., Package Change| Exidine (chlorhexidine gluconate) Topical Aerosol, Xttrium Laboratories, Inc., Package Change | Chlorhexidine Gluconate Dental Solution, Xttrium Laboratories, Inc., Approval | ChloraPrep One-Step Sepp (chlorhexidine gluconate and isopropyl alcohol) Topical Swab, CareFusion, LLC, Labeling Revision | ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) Sponge, Enturia Inc., Labeling Revision | ChloraPrep One-Step Frepp (chlorhexidine gluconate and isopropyl alcohol) Sponge, Enturia Inc., Labeling Revision | ChloraPrep One-Step with Tint (chlorhexidine gluconate and isopropyl alcohol) Sponge, Enturia Inc., Labeling Revision | Peridex (chlorhexidine gluconate) Solution, 3M ESPE Dental Products, Manufacturing Supplement | PerioChip (chlorhexidine gluconate) Dental Tablets, Dexcel Pharma Technologies, Ltd., Labeling Revision | Periochip, chlorhexidine gluconate, Tablet; Dental, Dexcel Pharma, Labeling Revision

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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