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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
  
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