FDA.reportPublic FDA data

Application 020832

Type
NDA
Sponsor
BECTON DICKINSON CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORAPREP ONE-STEPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSPONGE;TOPICAL2%;70% (3ML)YesYes
002CHLORAPREP WITH TINTCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSPONGE;TOPICAL2%;70% (26ML)YesYes
003CHLORAPREP ONE-STEP FREPPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSPONGE;TOPICAL2%;70% (1.5ML)YesYes
004CHLORAPREP ONE-STEPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSPONGE;TOPICAL2%;70% (10.5ML)YesYes
005CHLORAPREP WITH TINTCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSPONGE;TOPICAL2%;70% (10.5ML)YesYes
006CHLORAPREP ONE-STEPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSPONGE;TOPICAL2%;70% (26ML)YesYes
007CHLORAPREP WITH TINTCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSPONGE;TOPICAL2%;70% (3ML)YesYes
008CHLORAPREP ONE-STEPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSPONGE;TOPICAL2%;70% (1ML)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
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
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
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
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
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
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
58225SUPPL2019-04-05
58224SUPPL2019-04-05
49822SUPPL2017-09-21
49806SUPPL2017-09-19
13551SUPPL2014-07-31
25989SUPPL2014-07-01
35464SUPPL2014-01-15
35463SUPPL2014-01-15
13549SUPPL2014-01-15
13550SUPPL2013-11-20
25988SUPPL2013-10-11
3494SUPPL2013-01-10
25987SUPPL2012-08-17
25986SUPPL2012-08-17
3493SUPPL2012-08-17
3492SUPPL2010-07-23
25985SUPPL2010-03-08
25984SUPPL2008-10-24
3488SUPPL2008-06-06
20992SUPPL2007-12-06
13548SUPPL2007-05-16
3491SUPPL2007-05-16
25983SUPPL2006-12-28
3489SUPPL2006-12-04
35462SUPPL2006-11-22
3490SUPPL2006-10-18
3487SUPPL2006-10-18
13547SUPPL2006-10-11
25981SUPPL2006-04-07
25982SUPPL2006-01-06
13546SUPPL2005-05-04
3486SUPPL2005-05-04
3485SUPPL2004-07-07
44467SUPPL2004-06-16
25980SUPPL2004-06-15
35461SUPPL2003-08-28
25979SUPPL2003-08-28
35460SUPPL2002-04-26
3484SUPPL2002-04-26
20991ORIG2000-07-14
3483ORIG2000-07-14