Application 020832
- Type
- NDA
- Sponsor
- BECTON DICKINSON CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | SPONGE;TOPICAL | 2%;70% (3ML) | Yes | Yes |
| 002 | CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | SPONGE;TOPICAL | 2%;70% (26ML) | Yes | Yes |
| 003 | CHLORAPREP ONE-STEP FREPP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | SPONGE;TOPICAL | 2%;70% (1.5ML) | Yes | Yes |
| 004 | CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | SPONGE;TOPICAL | 2%;70% (10.5ML) | Yes | Yes |
| 005 | CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | SPONGE;TOPICAL | 2%;70% (10.5ML) | Yes | Yes |
| 006 | CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | SPONGE;TOPICAL | 2%;70% (26ML) | Yes | Yes |
| 007 | CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | SPONGE;TOPICAL | 2%;70% (3ML) | Yes | Yes |
| 008 | CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | SPONGE;TOPICAL | 2%;70% (1ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020832-001 | CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (3ML) | SPONGE / TOPICAL | RLD, RS | 2000-07-14 | |
| N020832-002 | CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (26ML) | SPONGE / TOPICAL | RLD, RS | 2005-05-03 | |
| N020832-003 | CHLORAPREP ONE-STEP FREPP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (1.5ML) | SPONGE / TOPICAL | RLD, RS | 2002-04-26 | |
| N020832-004 | CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (10.5ML) | SPONGE / TOPICAL | RLD, RS | 2003-08-20 | |
| N020832-005 | CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (10.5ML) | SPONGE / TOPICAL | RLD, RS | 2006-04-03 | |
| N020832-006 | CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-11-21 | |
| N020832-007 | CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (3ML) | SPONGE / TOPICAL | RLD, RS | 2006-10-10 | |
| N020832-008 | CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (1ML) | SPONGE / TOPICAL | RLD, RS | 2008-10-23 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N020832-002 | 7422388 | 2027-04-25 | U-1397 | Drug product | 2013-05-22 |
| N020832-005 | 7422388 | 2027-04-25 | U-1397 | Drug product | |
| N020832-007 | 7422388 | 2027-04-25 | U-1397 | Drug product |
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 | N020832-001 | CHLORAPREP ONE-STEP | 2%;70% (3ML) | SPONGE / TOPICAL | RLD, RS | 2000-07-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020832-002 | CHLORAPREP WITH TINT | 2%;70% (26ML) | SPONGE / TOPICAL | RLD, RS | 2005-05-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020832-003 | CHLORAPREP ONE-STEP FREPP | 2%;70% (1.5ML) | SPONGE / TOPICAL | RLD, RS | 2002-04-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020832-004 | CHLORAPREP ONE-STEP | 2%;70% (10.5ML) | SPONGE / TOPICAL | RLD, RS | 2003-08-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020832-005 | CHLORAPREP WITH TINT | 2%;70% (10.5ML) | SPONGE / TOPICAL | RLD, RS | 2006-04-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020832-006 | CHLORAPREP ONE-STEP | 2%;70% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-11-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020832-007 | CHLORAPREP WITH TINT | 2%;70% (3ML) | SPONGE / TOPICAL | RLD, RS | 2006-10-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020832-008 | CHLORAPREP ONE-STEP | 2%;70% (1ML) | SPONGE / TOPICAL | RLD, RS | 2008-10-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020832-001 | CHLORAPREP ONE-STEP | 2%;70% (3ML) | SPONGE / TOPICAL | RLD, RS | 2000-07-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020832-002 | CHLORAPREP WITH TINT | 2%;70% (26ML) | SPONGE / TOPICAL | RLD, RS | 2005-05-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020832-003 | CHLORAPREP ONE-STEP FREPP | 2%;70% (1.5ML) | SPONGE / TOPICAL | RLD, RS | 2002-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020832-004 | CHLORAPREP ONE-STEP | 2%;70% (10.5ML) | SPONGE / TOPICAL | RLD, RS | 2003-08-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020832-005 | CHLORAPREP WITH TINT | 2%;70% (10.5ML) | SPONGE / TOPICAL | RLD, RS | 2006-04-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020832-006 | CHLORAPREP ONE-STEP | 2%;70% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-11-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020832-007 | CHLORAPREP WITH TINT | 2%;70% (3ML) | SPONGE / TOPICAL | RLD, RS | 2006-10-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020832-008 | CHLORAPREP ONE-STEP | 2%;70% (1ML) | SPONGE / TOPICAL | RLD, RS | 2008-10-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020832-001 | CHLORAPREP ONE-STEP | 2%;70% (3ML) | SPONGE / TOPICAL | RLD, RS | 2000-07-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020832-002 | CHLORAPREP WITH TINT | 2%;70% (26ML) | SPONGE / TOPICAL | RLD, RS | 2005-05-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020832-003 | CHLORAPREP ONE-STEP FREPP | 2%;70% (1.5ML) | SPONGE / TOPICAL | RLD, RS | 2002-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020832-004 | CHLORAPREP ONE-STEP | 2%;70% (10.5ML) | SPONGE / TOPICAL | RLD, RS | 2003-08-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020832-005 | CHLORAPREP WITH TINT | 2%;70% (10.5ML) | SPONGE / TOPICAL | RLD, RS | 2006-04-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020832-006 | CHLORAPREP ONE-STEP | 2%;70% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-11-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020832-007 | CHLORAPREP WITH TINT | 2%;70% (3ML) | SPONGE / TOPICAL | RLD, RS | 2006-10-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020832-008 | CHLORAPREP ONE-STEP | 2%;70% (1ML) | SPONGE / TOPICAL | RLD, RS | 2008-10-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020832-001 | CHLORAPREP ONE-STEP | 2%;70% (3ML) | SPONGE / TOPICAL | RLD, RS | 2000-07-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020832-002 | CHLORAPREP WITH TINT | 2%;70% (26ML) | SPONGE / TOPICAL | RLD, RS | 2005-05-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020832-003 | CHLORAPREP ONE-STEP FREPP | 2%;70% (1.5ML) | SPONGE / TOPICAL | RLD, RS | 2002-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020832-004 | CHLORAPREP ONE-STEP | 2%;70% (10.5ML) | SPONGE / TOPICAL | RLD, RS | 2003-08-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020832-005 | CHLORAPREP WITH TINT | 2%;70% (10.5ML) | SPONGE / TOPICAL | RLD, RS | 2006-04-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020832-006 | CHLORAPREP ONE-STEP | 2%;70% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-11-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020832-007 | CHLORAPREP WITH TINT | 2%;70% (3ML) | SPONGE / TOPICAL | RLD, RS | 2006-10-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020832-008 | CHLORAPREP ONE-STEP | 2%;70% (1ML) | SPONGE / TOPICAL | RLD, RS | 2008-10-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020832-001 | CHLORAPREP ONE-STEP | 2%;70% (3ML) | SPONGE / TOPICAL | RLD, RS | 2000-07-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020832-002 | CHLORAPREP WITH TINT | 2%;70% (26ML) | SPONGE / TOPICAL | RLD, RS | 2005-05-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020832-003 | CHLORAPREP ONE-STEP FREPP | 2%;70% (1.5ML) | SPONGE / TOPICAL | RLD, RS | 2002-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020832-004 | CHLORAPREP ONE-STEP | 2%;70% (10.5ML) | SPONGE / TOPICAL | RLD, RS | 2003-08-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020832-005 | CHLORAPREP WITH TINT | 2%;70% (10.5ML) | SPONGE / TOPICAL | RLD, RS | 2006-04-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020832-006 | CHLORAPREP ONE-STEP | 2%;70% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-11-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020832-007 | CHLORAPREP WITH TINT | 2%;70% (3ML) | SPONGE / TOPICAL | RLD, RS | 2006-10-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020832-008 | CHLORAPREP ONE-STEP | 2%;70% (1ML) | SPONGE / TOPICAL | RLD, RS | 2008-10-23 | fd3edfee7708… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N020832-002 | 7422388 | 2027-04-25 | U-1397 | Drug product | 2013-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020832-005 | 7422388 | 2027-04-25 | U-1397 | Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020832-007 | 7422388 | 2027-04-25 | U-1397 | Drug product | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020832-002 | 7422388 | 2027-04-25 | U-1397 | Drug product | 2013-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020832-005 | 7422388 | 2027-04-25 | U-1397 | Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020832-007 | 7422388 | 2027-04-25 | U-1397 | Drug product | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020832-002 | 7422388 | 2027-04-25 | U-1397 | Drug product | 2013-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020832-005 | 7422388 | 2027-04-25 | U-1397 | Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020832-007 | 7422388 | 2027-04-25 | U-1397 | Drug product | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020832-002 | 7422388 | 2027-04-25 | U-1397 | Drug product | 2013-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020832-005 | 7422388 | 2027-04-25 | U-1397 | Drug product | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020832-007 | 7422388 | 2027-04-25 | U-1397 | Drug product | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020832-002 | 7422388 | 2027-04-25 | U-1397 | Drug product | 2013-05-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020832-005 | 7422388 | 2027-04-25 | U-1397 | Drug product | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020832-007 | 7422388 | 2027-04-25 | U-1397 | Drug product | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020832-002 | 7422388 | 2027-04-25 | U-1397 | Drug product | 2013-05-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020832-005 | 7422388 | 2027-04-25 | U-1397 | Drug product | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020832-007 | 7422388 | 2027-04-25 | U-1397 | Drug product | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020832-002 | 6991394 | 2024-01-31 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020832-002 | 7422388 | 2027-04-25 | U-1397 | Drug product | 2013-05-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020832-005 | 7422388 | 2027-04-25 | U-1397 | Drug product | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020832-006 | 6991394 | 2024-01-31 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020832-007 | 7422388 | 2027-04-25 | U-1397 | Drug product | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020832-002 | 6991394 | 2024-01-31 | Drug product | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020832-002 | 7422388 | 2027-04-25 | U-1397 | Drug product | 2013-05-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020832-005 | 7422388 | 2027-04-25 | U-1397 | Drug product | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020832-006 | 6991394 | 2024-01-31 | Drug product | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020832-007 | 7422388 | 2027-04-25 | U-1397 | Drug product | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020832-002 | 6991394 | 2024-01-31 | Drug product | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020832-002 | 7422388 | 2027-04-25 | U-1397 | Drug product | 2013-05-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020832-005 | 7422388 | 2027-04-25 | U-1397 | Drug product | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020832-006 | 6991394 | 2024-01-31 | Drug product | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020832-007 | 7422388 | 2027-04-25 | U-1397 | Drug product | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020832-002 | 6991394 | 2024-01-31 | Drug product | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020832-002 | 7422388 | 2027-04-25 | U-1397 | Drug product | 2013-05-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020832-005 | 7422388 | 2027-04-25 | U-1397 | Drug product | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020832-006 | 6991394 | 2024-01-31 | Drug product | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020832-007 | 7422388 | 2027-04-25 | U-1397 | Drug product | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020832-002 | 6991394 | 2024-01-31 | Drug product | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020832-002 | 7422388 | 2027-04-25 | U-1397 | Drug product | 2013-05-22 | d06236e962d9… |
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 |
|---|---|---|---|---|---|---|
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 85291b2b-40b9-07fa-e053-2a91aa0a84e4 | 2025-11-04 | Warnings | 020832 NDA020832 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 85416361-90b5-3efa-e053-2a91aa0af431 | 2025-11-03 | Warnings | 020832 NDA020832 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 8528a4f5-5ff4-45f3-e053-2991aa0a804c | 2025-11-03 | Warnings | 020832 NDA020832 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 8529596f-37e4-c44e-e053-2a91aa0ad014 | 2025-10-30 | Warnings | 020832 NDA020832 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 8578da30-a155-2505-e053-2991aa0a2c04 | 2025-10-29 | Warnings | 020832 NDA020832 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 8541f219-c060-399a-e053-2991aa0ab05c | 2025-10-24 | Warnings | 020832 NDA020832 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 8541a1ed-2a92-1fab-e053-2a91aa0a29d1 | 2025-10-23 | Warnings | 020832 NDA020832 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 85790749-5a95-7f18-e053-2a91aa0a1a02 | 2025-10-17 | Warnings | 020832 NDA020832 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 85791e13-4103-19fe-e053-2991aa0a647f | 2025-10-17 | Warnings | 020832 NDA020832 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 85794f6b-d1ea-40f9-e053-2991aa0a8823 | 2025-10-17 | Warnings | 020832 NDA020832 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213 LLC | f06e4f9d-6cef-b57a-e053-2a95a90a7337 | 2025-07-03 | Warnings | 54365-400 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213 LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | CareFusion 213, LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58225 | SUPPL | 2019-04-05 |
| 58224 | SUPPL | 2019-04-05 |
| 49822 | SUPPL | 2017-09-21 |
| 49806 | SUPPL | 2017-09-19 |
| 13551 | SUPPL | 2014-07-31 |
| 25989 | SUPPL | 2014-07-01 |
| 35464 | SUPPL | 2014-01-15 |
| 35463 | SUPPL | 2014-01-15 |
| 13549 | SUPPL | 2014-01-15 |
| 13550 | SUPPL | 2013-11-20 |
| 25988 | SUPPL | 2013-10-11 |
| 3494 | SUPPL | 2013-01-10 |
| 25987 | SUPPL | 2012-08-17 |
| 25986 | SUPPL | 2012-08-17 |
| 3493 | SUPPL | 2012-08-17 |
| 3492 | SUPPL | 2010-07-23 |
| 25985 | SUPPL | 2010-03-08 |
| 25984 | SUPPL | 2008-10-24 |
| 3488 | SUPPL | 2008-06-06 |
| 20992 | SUPPL | 2007-12-06 |
| 13548 | SUPPL | 2007-05-16 |
| 3491 | SUPPL | 2007-05-16 |
| 25983 | SUPPL | 2006-12-28 |
| 3489 | SUPPL | 2006-12-04 |
| 35462 | SUPPL | 2006-11-22 |
| 3490 | SUPPL | 2006-10-18 |
| 3487 | SUPPL | 2006-10-18 |
| 13547 | SUPPL | 2006-10-11 |
| 25981 | SUPPL | 2006-04-07 |
| 25982 | SUPPL | 2006-01-06 |
| 13546 | SUPPL | 2005-05-04 |
| 3486 | SUPPL | 2005-05-04 |
| 3485 | SUPPL | 2004-07-07 |
| 44467 | SUPPL | 2004-06-16 |
| 25980 | SUPPL | 2004-06-15 |
| 35461 | SUPPL | 2003-08-28 |
| 25979 | SUPPL | 2003-08-28 |
| 35460 | SUPPL | 2002-04-26 |
| 3484 | SUPPL | 2002-04-26 |
| 20991 | ORIG | 2000-07-14 |
| 3483 | ORIG | 2000-07-14 |