BECTON DICKINSON CO FDA Approval NDA 020832

NDA 020832

BECTON DICKINSON CO

FDA Drug Application

Application #020832

Documents

Letter2000-07-14
Letter2002-04-26
Letter2004-07-07
Letter2005-05-04
Letter2006-10-18
Letter2008-06-06
Letter2006-12-04
Letter2006-10-18
Letter2007-05-16
Letter2010-07-23
Letter2012-08-17
Letter2013-01-10
Label2005-05-04
Label2006-10-11
Label2007-05-16
Label2014-01-15
Label2013-11-20
Label2014-07-31
Review2000-07-14
Review2007-12-06
Letter2003-08-28
Letter2004-06-15
Letter2006-04-07
Letter2006-01-06
Letter2006-12-28
Letter2008-10-24
Letter2010-03-08
Letter2012-08-17
Letter2012-08-17
Letter2013-10-11
Letter2014-07-01
Label2002-04-26
Label2003-08-28
Label2006-11-22
Label2014-01-15
Label2014-01-15
Other2004-06-16
Letter2017-09-19
Label2017-09-21
Label2019-04-05
Letter2019-04-05

Application Sponsors

NDA 020832BECTON DICKINSON CO

Marketing Status

Over-the-counter001
Over-the-counter002
Over-the-counter003
Over-the-counter004
Over-the-counter005
Over-the-counter006
Over-the-counter007
Over-the-counter008

Application Products

001SPONGE;TOPICAL2%;70% (3ML)1CHLORAPREP ONE-STEPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
002SPONGE;TOPICAL2%;70% (26ML)1CHLORAPREP WITH TINTCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
003SPONGE;TOPICAL2%;70% (1.5ML)1CHLORAPREP ONE-STEP FREPPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
004SPONGE;TOPICAL2%;70% (10.5ML)1CHLORAPREP ONE-STEPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
005SPONGE;TOPICAL2%;70% (10.5ML)1CHLORAPREP WITH TINTCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
006SPONGE;TOPICAL2%;70% (26ML)1CHLORAPREP ONE-STEPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
007SPONGE;TOPICAL2%;70% (3ML)1CHLORAPREP WITH TINTCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
008SPONGE;TOPICAL2%;70% (1ML)1CHLORAPREP ONE-STEPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2000-07-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2002-04-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2003-08-20STANDARD
LABELING; LabelingSUPPL6AP2004-06-10STANDARD
LABELING; LabelingSUPPL7AP2004-07-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2005-05-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2006-04-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2005-12-27STANDARD
LABELING; LabelingSUPPL12AP2006-12-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2006-10-10N/A
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2008-06-03N/A
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2006-11-21N/A
LABELING; LabelingSUPPL16AP2006-10-11STANDARD
LABELING; LabelingSUPPL18AP2007-05-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2008-10-23N/A
LABELING; LabelingSUPPL25AP2010-03-03UNKNOWN
LABELING; LabelingSUPPL26AP2010-07-20UNKNOWN
LABELING; LabelingSUPPL27AP2012-08-16STANDARD
LABELING; LabelingSUPPL28AP2012-08-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL29AP2012-12-27STANDARD
LABELING; LabelingSUPPL30AP2012-08-16STANDARD
LABELING; LabelingSUPPL31AP2013-10-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL33AP2014-02-12STANDARD
LABELING; LabelingSUPPL34AP2014-06-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2015-06-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL36AP2019-04-03N/A
MANUF (CMC); Manufacturing (CMC)SUPPL37AP2016-06-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL38AP2019-04-03N/A
LABELING; LabelingSUPPL42AP2017-09-12STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL8Null0
SUPPL10Null0
SUPPL11Null0
SUPPL25Null6
SUPPL26Null6
SUPPL27Null7
SUPPL28Null7
SUPPL29Null0
SUPPL30Null15
SUPPL31Null6
SUPPL33Null0
SUPPL34Null15
SUPPL35Null0
SUPPL37Null0
SUPPL42Null15

CDER Filings

BECTON DICKINSON CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20832
            [companyName] => BECTON DICKINSON CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORAPREP ONE-STEP","activeIngredients":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","strength":"2%;70% (3ML)","dosageForm":"SPONGE;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CHLORAPREP ONE-STEP","activeIngredients":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","strength":"2%;70% (10.5ML)","dosageForm":"SPONGE;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CHLORAPREP ONE-STEP","activeIngredients":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","strength":"2%;70% (26ML)","dosageForm":"SPONGE;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CHLORAPREP ONE-STEP","activeIngredients":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","strength":"2%;70% (1ML)","dosageForm":"SPONGE;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CHLORAPREP ONE-STEP FREPP","activeIngredients":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","strength":"2%;70% (1.5ML)","dosageForm":"SPONGE;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CHLORAPREP WITH TINT","activeIngredients":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","strength":"2%;70% (26ML)","dosageForm":"SPONGE;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CHLORAPREP WITH TINT","activeIngredients":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","strength":"2%;70% (10.5ML)","dosageForm":"SPONGE;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CHLORAPREP WITH TINT","activeIngredients":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","strength":"2%;70% (3ML)","dosageForm":"SPONGE;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/03\/2019","submission":"SUPPL-36","supplementCategories":"Manufacturing (CMC)-Manufacturing Process","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020832Orig1s036_REPLACEMENT_lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2017","submission":"SUPPL-42","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020832Orig1s042lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2014","submission":"SUPPL-34","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"10\/10\/2013","submission":"SUPPL-31","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"08\/16\/2012","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"08\/16\/2012","submission":"SUPPL-30","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"08\/16\/2012","submission":"SUPPL-28","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"08\/16\/2012","submission":"SUPPL-27","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"05\/09\/2007","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020832s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2006","submission":"SUPPL-15","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020832s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2006","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020832s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2005","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020832s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2003","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20832scp004_chloraprep_lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2002","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20832s2lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"CHLORAPREP ONE-STEP","submission":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","actionType":"2%;70% (3ML)","submissionClassification":"SPONGE;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CHLORAPREP ONE-STEP","submission":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","actionType":"2%;70% (10.5ML)","submissionClassification":"SPONGE;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CHLORAPREP ONE-STEP","submission":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","actionType":"2%;70% (26ML)","submissionClassification":"SPONGE;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CHLORAPREP ONE-STEP","submission":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","actionType":"2%;70% (1ML)","submissionClassification":"SPONGE;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CHLORAPREP ONE-STEP FREPP","submission":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","actionType":"2%;70% (1.5ML)","submissionClassification":"SPONGE;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CHLORAPREP WITH TINT","submission":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","actionType":"2%;70% (26ML)","submissionClassification":"SPONGE;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CHLORAPREP WITH TINT","submission":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","actionType":"2%;70% (10.5ML)","submissionClassification":"SPONGE;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CHLORAPREP WITH TINT","submission":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","actionType":"2%;70% (3ML)","submissionClassification":"SPONGE;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-04-03
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.