Application 021586
- Type
- NDA
- Sponsor
- 3M
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DURAPREP | IODINE POVACRYLEX; ISOPROPYL ALCOHOL | SPONGE;TOPICAL | EQ 0.7% IODINE;74% (6ML) | Yes | Yes |
| 002 | DURAPREP | IODINE POVACRYLEX; ISOPROPYL ALCOHOL | SPONGE;TOPICAL | EQ 0.7% IODINE;74% (26ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021586-001 | DURAPREP | IODINE POVACRYLEX; ISOPROPYL ALCOHOL | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | |
| N021586-002 | DURAPREP | IODINE POVACRYLEX; ISOPROPYL ALCOHOL | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | bb7c543d1eb4… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3M DuraPrep Surgical | IODINE POVACRYLEX AND ISOPROPYL ALCOHOL | Solventum US LLC | 22a10a54-6a04-48b3-9ec4-b26526183daf | 2026-04-23 | Warnings | 021586 NDA021586 17518-011 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17518-011 | 3M DuraPrep Surgical | Iodine povacrylex and Isopropyl alcohol | 3M Health Care | NDA | Current |
| 17518-011 | 3M DuraPrep Surgical | Iodine povacrylex and Isopropyl alcohol | 3M Health Care | NDA | Current |
| 17518-011 | 3M DuraPrep Surgical | Iodine povacrylex and Isopropyl alcohol | 3M Company | NDA | Current |
| 17518-011 | 3M DuraPrep Surgical | Iodine povacrylex and Isopropyl alcohol | 3M Health Care | NDA | Current |
| 17518-011 | 3M DuraPrep Surgical | Iodine Povacrylex and Isopropyl Alcohol | 3M Company | NDA | Current |
| 17518-011 | 3M DuraPrep Surgical | Iodine povacrylex and Isopropyl alcohol | 3M Health Care | NDA | Current |
| 17518-011 | 3M DuraPrep Surgical | Iodine povacrylex and Isopropyl alcohol | 3M Company | NDA | Current |
| 17518-011 | 3M DuraPrep Surgical | Iodine Povacrylex and Isopropyl Alcohol | 3M Company | NDA | Current |