Documents
Application Sponsors
Marketing Status
| Over-the-counter | 001 |
| Over-the-counter | 002 |
Application Products
| 001 | SPONGE;TOPICAL | EQ 0.7% IODINE;74% (6ML) | 1 | DURAPREP | IODINE POVACRYLEX; ISOPROPYL ALCOHOL |
| 002 | SPONGE;TOPICAL | EQ 0.7% IODINE;74% (26ML) | 1 | DURAPREP | IODINE POVACRYLEX; ISOPROPYL ALCOHOL |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2006-09-29 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2010-03-11 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2013-02-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2013-07-10 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-06-08 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 15 |
CDER Filings
3M
cder:Array
(
[0] => Array
(
[ApplNo] => 21586
[companyName] => 3M
[docInserts] => ["",""]
[products] => [{"drugName":"DURAPREP","activeIngredients":"IODINE POVACRYLEX; ISOPROPYL ALCOHOL","strength":"EQ 0.7% IODINE;74% (6ML)","dosageForm":"SPONGE;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"DURAPREP","activeIngredients":"IODINE POVACRYLEX; ISOPROPYL ALCOHOL","strength":"EQ 0.7% IODINE;74% (26ML)","dosageForm":"SPONGE;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"06\/08\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021586Orig1s005lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DURAPREP","submission":"IODINE POVACRYLEX; ISOPROPYL ALCOHOL","actionType":"EQ 0.7% IODINE;74% (6ML)","submissionClassification":"SPONGE;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"DURAPREP","submission":"IODINE POVACRYLEX; ISOPROPYL ALCOHOL","actionType":"EQ 0.7% IODINE;74% (26ML)","submissionClassification":"SPONGE;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2015-06-08
)
)