Documents
Application Sponsors
Marketing Status
| Over-the-counter | 001 |
| Over-the-counter | 002 |
Application Products
| 001 | SOLUTION;TOPICAL | 2% | 0 | CIDA-STAT | CHLORHEXIDINE GLUCONATE |
| 002 | SOLUTION;TOPICAL | 4% | 0 | CHG SCRUB | CHLORHEXIDINE GLUCONATE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1986-07-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1987-06-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1993-05-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1993-05-06 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1995-12-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-08-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2001-04-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2005-02-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2002-07-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2002-12-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2006-04-03 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2010-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2012-05-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2014-12-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2015-08-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2015-12-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2016-01-14 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2018-01-10 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 26 | Null | 7 |
CDER Filings
ECOLAB
cder:Array
(
[0] => Array
(
[ApplNo] => 19258
[companyName] => ECOLAB
[docInserts] => ["",""]
[products] => [{"drugName":"CHG SCRUB","activeIngredients":"CHLORHEXIDINE GLUCONATE","strength":"4%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"CIDA-STAT","activeIngredients":"CHLORHEXIDINE GLUCONATE","strength":"2%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"01\/10\/2018","submission":"SUPPL-26","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019258Orig1s026lbl.pdf\"}]","notes":""},{"actionDate":"01\/14\/2016","submission":"SUPPL-23","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019258Orig1s023lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
[originalApprovals] => [{"actionDate":"CHG SCRUB","submission":"CHLORHEXIDINE GLUCONATE","actionType":"4%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"CIDA-STAT","submission":"CHLORHEXIDINE GLUCONATE","actionType":"2%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2018-01-10
)
)