Documents
Application Sponsors
| NDA 021555 | BECTON DICKINSON CO | |
Marketing Status
| Over-the-counter | 001 |
| Over-the-counter | 002 |
| Over-the-counter | 003 |
Application Products
| 001 | SWAB;TOPICAL | 2%;70% (0.67ML) | 1 | CHLORAPREP ONE-STEP SEPP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
| 002 | SWAB;TOPICAL | 2%;70% (1.75ML) | 1 | CHLORAPREP SINGLE SWABSTICK | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
| 003 | SWAB;TOPICAL | 2%;70% (5.25ML) | 1 | CHLORAPREP TRIPLE SWABSTICK | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2002-10-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2009-06-10 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2005-12-27 | N/A |
| LABELING; Labeling | SUPPL | 7 | AP | 2006-12-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2007-08-09 | N/A |
| LABELING; Labeling | SUPPL | 14 | AP | 2010-03-02 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2010-07-20 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2012-08-16 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2012-08-16 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2013-10-10 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2014-06-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2017-12-22 | N/A |
| LABELING; Labeling | SUPPL | 24 | AP | 2017-09-12 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Null | 15 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 24 | Null | 15 |
CDER Filings
BECTON DICKINSON CO
cder:Array
(
[0] => Array
(
[ApplNo] => 21555
[companyName] => BECTON DICKINSON CO
[docInserts] => ["",""]
[products] => [{"drugName":"CHLORAPREP ONE-STEP SEPP","activeIngredients":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","strength":"2%;70% (0.67ML)","dosageForm":"SWAB;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CHLORAPREP SINGLE SWABSTICK","activeIngredients":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","strength":"2%;70% (1.75ML)","dosageForm":"SWAB;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CHLORAPREP TRIPLE SWABSTICK","activeIngredients":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","strength":"2%;70% (5.25ML)","dosageForm":"SWAB;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"12\/22\/2017","submission":"SUPPL-20","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021555Origs020lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"09\/12\/2017","submission":"SUPPL-24","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/21555Orig1s024lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2017","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/21555Orig1s024lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2014","submission":"SUPPL-19","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"10\/10\/2013","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"08\/16\/2012","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"08\/16\/2012","submission":"SUPPL-17","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"08\/16\/2012","submission":"SUPPL-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"08\/09\/2007","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021555s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2007","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021555s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21555lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CHLORAPREP ONE-STEP SEPP","submission":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","actionType":"2%;70% (0.67ML)","submissionClassification":"SWAB;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CHLORAPREP SINGLE SWABSTICK","submission":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","actionType":"2%;70% (1.75ML)","submissionClassification":"SWAB;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CHLORAPREP TRIPLE SWABSTICK","submission":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","actionType":"2%;70% (5.25ML)","submissionClassification":"SWAB;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-12-22
)
)