Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020832

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CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL)
2%;70% (3ML)
Marketing Status: Over-the-counter
Active Ingredient: CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Proprietary Name: CHLORAPREP ONE-STEP
Dosage Form; Route of Administration: SPONGE; TOPICAL
Strength: 2%;70% (3ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020832
Product Number: 001
Approval Date: Jul 14, 2000
Applicant Holder Full Name: BECTON DICKINSON AND CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL)
2%;70% (10.5ML)
Marketing Status: Over-the-counter
Active Ingredient: CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Proprietary Name: CHLORAPREP ONE-STEP
Dosage Form; Route of Administration: SPONGE; TOPICAL
Strength: 2%;70% (10.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020832
Product Number: 004
Approval Date: Aug 20, 2003
Applicant Holder Full Name: BECTON DICKINSON AND CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL)
2%;70% (26ML)
Marketing Status: Over-the-counter
Active Ingredient: CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Proprietary Name: CHLORAPREP ONE-STEP
Dosage Form; Route of Administration: SPONGE; TOPICAL
Strength: 2%;70% (26ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020832
Product Number: 006
Approval Date: Nov 21, 2006
Applicant Holder Full Name: BECTON DICKINSON AND CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL)
2%;70% (1ML)
Marketing Status: Over-the-counter
Active Ingredient: CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Proprietary Name: CHLORAPREP ONE-STEP
Dosage Form; Route of Administration: SPONGE; TOPICAL
Strength: 2%;70% (1ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020832
Product Number: 008
Approval Date: Oct 23, 2008
Applicant Holder Full Name: BECTON DICKINSON AND CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CHLORAPREP ONE-STEP FREPP (CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL)
2%;70% (1.5ML)
Marketing Status: Over-the-counter
Active Ingredient: CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Proprietary Name: CHLORAPREP ONE-STEP FREPP
Dosage Form; Route of Administration: SPONGE; TOPICAL
Strength: 2%;70% (1.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020832
Product Number: 003
Approval Date: Apr 26, 2002
Applicant Holder Full Name: BECTON DICKINSON AND CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CHLORAPREP WITH TINT (CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL)
2%;70% (3ML)
Marketing Status: Over-the-counter
Active Ingredient: CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Proprietary Name: CHLORAPREP WITH TINT
Dosage Form; Route of Administration: SPONGE; TOPICAL
Strength: 2%;70% (3ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020832
Product Number: 007
Approval Date: Oct 10, 2006
Applicant Holder Full Name: BECTON DICKINSON AND CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CHLORAPREP WITH TINT (CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL)
2%;70% (10.5ML)
Marketing Status: Over-the-counter
Active Ingredient: CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Proprietary Name: CHLORAPREP WITH TINT
Dosage Form; Route of Administration: SPONGE; TOPICAL
Strength: 2%;70% (10.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020832
Product Number: 005
Approval Date: Apr 3, 2006
Applicant Holder Full Name: BECTON DICKINSON AND CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CHLORAPREP WITH TINT (CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL)
2%;70% (26ML)
Marketing Status: Over-the-counter
Active Ingredient: CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Proprietary Name: CHLORAPREP WITH TINT
Dosage Form; Route of Administration: SPONGE; TOPICAL
Strength: 2%;70% (26ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020832
Product Number: 002
Approval Date: May 3, 2005
Applicant Holder Full Name: BECTON DICKINSON AND CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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