FDA.reportPublic FDA data

Application 021555

Type
NDA
Sponsor
BECTON DICKINSON CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORAPREP ONE-STEP SEPPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSWAB;TOPICAL2%;70% (0.67ML)YesYes
002CHLORAPREP SINGLE SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSWAB;TOPICAL2%;70% (1.75ML)YesYes
003CHLORAPREP TRIPLE SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSWAB;TOPICAL2%;70% (5.25ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-StepChlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75331SUPPL 2023-08-31
75330SUPPL 2023-08-31
50913SUPPL2017-12-27
49823SUPPL2017-09-21
49755SUPPL2017-09-12
37218SUPPL2014-07-31
28109SUPPL2014-07-01
37216SUPPL2014-01-15
15775SUPPL2014-01-15
37217SUPPL2013-11-20
5732SUPPL2013-10-11
5731SUPPL2012-08-17
5730SUPPL2012-08-17
5729SUPPL2010-07-23
28106SUPPL2009-06-16
37215SUPPL2007-08-14
28108SUPPL2007-08-14
28107SUPPL2006-12-28
5728SUPPL2006-01-06
5727SUPPL2005-05-17
42210ORIG2005-01-11
15774ORIG2002-10-07
5726ORIG2002-10-07