Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021555

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CHLORAPREP ONE-STEP SEPP (CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL)
2%;70% (0.67ML)
Marketing Status: Over-the-counter

Active Ingredient: CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Proprietary Name: CHLORAPREP ONE-STEP SEPP
Dosage Form; Route of Administration: SWAB; TOPICAL
Strength: 2%;70% (0.67ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021555
Product Number: 001
Approval Date: Oct 7, 2002
Applicant Holder Full Name: BECTON DICKINSON AND CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

CHLORAPREP SINGLE SWABSTICK (CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL)
2%;70% (1.75ML)
Marketing Status: Over-the-counter

Active Ingredient: CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Proprietary Name: CHLORAPREP SINGLE SWABSTICK
Dosage Form; Route of Administration: SWAB; TOPICAL
Strength: 2%;70% (1.75ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021555
Product Number: 002
Approval Date: May 10, 2005
Applicant Holder Full Name: BECTON DICKINSON AND CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

CHLORAPREP TRIPLE SWABSTICK (CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL)
2%;70% (5.25ML)
Marketing Status: Over-the-counter

Active Ingredient: CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Proprietary Name: CHLORAPREP TRIPLE SWABSTICK
Dosage Form; Route of Administration: SWAB; TOPICAL
Strength: 2%;70% (5.25ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021555
Product Number: 003
Approval Date: Jun 10, 2009
Applicant Holder Full Name: BECTON DICKINSON AND CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information