Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021586
Company: 3M
Company: 3M
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DURAPREP | IODINE POVACRYLEX; ISOPROPYL ALCOHOL | EQ 0.7% IODINE;74% (6ML) | SPONGE;TOPICAL | Over-the-counter | None | Yes | Yes |
| DURAPREP | IODINE POVACRYLEX; ISOPROPYL ALCOHOL | EQ 0.7% IODINE;74% (26ML) | SPONGE;TOPICAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/29/2006 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021586s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021586s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/08/2015 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021586Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021586Orig1s005ltr.pdf | |
| 07/10/2013 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/2010 | SUPPL-2 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021586s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/08/2015 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021586Orig1s005lbl.pdf |
DURAPREP
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPONGE;TOPICAL; EQ 0.7% IODINE;74% (6ML)
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| DURAPREP | IODINE POVACRYLEX; ISOPROPYL ALCOHOL | EQ 0.7% IODINE;74% (6ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 021586 | 3M |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPONGE;TOPICAL; EQ 0.7% IODINE;74% (26ML)
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| DURAPREP | IODINE POVACRYLEX; ISOPROPYL ALCOHOL | EQ 0.7% IODINE;74% (26ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 021586 | 3M |