FDA.reportPublic FDA data

Application 021586

Type
NDA
Sponsor
3M

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DURAPREPIODINE POVACRYLEX; ISOPROPYL ALCOHOLSPONGE;TOPICALEQ 0.7% IODINE;74% (6ML)YesYes
002DURAPREPIODINE POVACRYLEX; ISOPROPYL ALCOHOLSPONGE;TOPICALEQ 0.7% IODINE;74% (26ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021586-001DURAPREPIODINE POVACRYLEX; ISOPROPYL ALCOHOLEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29
N021586-002DURAPREPIODINE POVACRYLEX; ISOPROPYL ALCOHOLEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29

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.

Product history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29782e0a99824c…
2021-12-28 21:50 UTC2021-12N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-2987673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-295aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-298869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-293f01610625f2…
2019-12-14 00:12 UTC2019-12N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-293f01610625f2…
2019-09-15 20:21 UTC2019-09N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29b00525d2431f…
2019-09-15 20:21 UTC2019-09N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29ea99ee380514…
2019-07-19 19:46 UTC2019-07N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-296a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-291c564ffb4f44…
2024-02-18 07:12 UTC2024-02N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-299b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-293f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29053a50430f4f…
2023-05-13 08:27 UTC2023-05N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-293bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-293a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-293a93d1ddd44b…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3M DuraPrep SurgicalIODINE POVACRYLEX AND ISOPROPYL ALCOHOLSolventum US LLC22a10a54-6a04-48b3-9ec4-b26526183daf2026-04-23WarningsExact identifier
application applno (NDA): 021586
application number: NDA021586
ndc (product): 17518-011

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17518-0113M DuraPrep SurgicalIodine povacrylex and Isopropyl alcohol3M Health CareNDACurrent
17518-0113M DuraPrep SurgicalIodine povacrylex and Isopropyl alcohol3M Health CareNDACurrent
17518-0113M DuraPrep SurgicalIodine povacrylex and Isopropyl alcohol3M CompanyNDACurrent
17518-0113M DuraPrep SurgicalIodine povacrylex and Isopropyl alcohol3M Health CareNDACurrent
17518-0113M DuraPrep SurgicalIodine Povacrylex and Isopropyl Alcohol3M CompanyNDACurrent
17518-0113M DuraPrep SurgicalIodine povacrylex and Isopropyl alcohol3M Health CareNDACurrent
17518-0113M DuraPrep SurgicalIodine povacrylex and Isopropyl alcohol3M CompanyNDACurrent
17518-0113M DuraPrep SurgicalIodine Povacrylex and Isopropyl Alcohol3M CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
15825SUPPL2015-06-19
28182SUPPL2015-06-10
5785SUPPL2010-03-18
21745ORIG2008-08-22
5784ORIG2006-10-05