Home Applications 208288 Application 208288
Type NDA
Sponsor 3M HEALTH CARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SOLUPREP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL SOLUTION;TOPICAL 2%;70% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208288-001 SOLUPREP S CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208288-001 M-292 2026-01-20
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 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 cb3db0bc1861…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 ea99ee380514…2023-01-26 05:58 UTC 2023-01 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 cb3db0bc1861…
Observed Orange Book exclusivity history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17518-080 3M SoluPrep chlorhexidine gluconate and isopropyl alcohol 3M Company NDA Current 17518-080 3M SoluPrep Chlorhexidine Gluconate and Isopropyl Alcohol 3M Company NDA Current 17518-080 3M SoluPrep chlorhexidine gluconate and isopropyl alcohol 3M Company NDA Current 17518-080 3M SoluPrep chlorhexidine gluconate and isopropyl alcohol 3M Company NDA Current 17518-080 3M SoluPrep chlorhexidine gluconate and isopropyl alcohol 3M Company NDA Current 17518-081 3M SoluPrep chlorhexidine gluconate and isopropyl alcohol 3M Company NDA Current 17518-081 3M SoluPrep chlorhexidine gluconate and isopropyl alcohol 3M Company NDA Current 17518-081 3M SoluPrep chlorhexidine gluconate and isopropyl alcohol 3M Company NDA Current 17518-081 3M SoluPrep chlorhexidine gluconate and isopropyl alcohol 3M Company NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 73277 SUPPL 2023-01-23 73267 SUPPL 2023-01-23 58222 ORIG 2019-04-05 55161 ORIG 2018-08-10 55137 ORIG 2018-08-08