Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020832
Company: BECTON DICKINSON CO
Company: BECTON DICKINSON CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (3ML) | SPONGE;TOPICAL | Over-the-counter | None | Yes | Yes |
| CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (10.5ML) | SPONGE;TOPICAL | Over-the-counter | None | Yes | Yes |
| CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (26ML) | SPONGE;TOPICAL | Over-the-counter | None | Yes | Yes |
| CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (1ML) | SPONGE;TOPICAL | Over-the-counter | None | Yes | Yes |
| CHLORAPREP ONE-STEP FREPP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (1.5ML) | SPONGE;TOPICAL | Over-the-counter | None | Yes | Yes |
| CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (26ML) | SPONGE;TOPICAL | Over-the-counter | None | Yes | Yes |
| CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (10.5ML) | SPONGE;TOPICAL | Over-the-counter | None | Yes | Yes |
| CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (3ML) | 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 |
|---|---|---|---|---|---|---|---|
| 07/14/2000 | 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/2000/20832ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-832_CHLORAPREP.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/12/2017 | SUPPL-42 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020832Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020832Orig1s042ltr.pdf | |
| 04/03/2019 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/07/2016 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/2019 | SUPPL-36 | Manufacturing (CMC)-Manufacturing Process |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020832Orig1s036_REPLACEMENT_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020832Orig1s036_REPLACEMENT_ltr.pdf | |
| 06/09/2015 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/2014 | SUPPL-34 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020832Orig1s034, 021555Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020832Orig1s034,021555Orig1s019ltr.pdf | |
| 02/12/2014 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/2013 | SUPPL-31 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020832Orig1s031, 021555Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020832Orig1s031,021555Orig1s018ltr.pdf | |
| 08/16/2012 | SUPPL-30 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Origs030, 021555Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Origs030,021555Orig1s017ltr.pdf | |
| 12/27/2012 | SUPPL-29 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Orig1s029ltr.pdf |
| 08/16/2012 | SUPPL-28 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Orig1s027, 020832Orig1s028, 021555Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Orig1s027,s028,021555Orig1s016ltr.pdf | |
| 08/16/2012 | SUPPL-27 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Orig1s027, 020832Orig1s028, 021555Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Orig1s027,s028,021555Orig1s016ltr.pdf | |
| 07/20/2010 | SUPPL-26 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020832s026ltr.pdf |
| 03/03/2010 | SUPPL-25 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020832s025ltr.pdf |
| 10/23/2008 | SUPPL-22 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020832s022ltr.pdf |
| 05/09/2007 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020832s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020832s018ltr.pdf | |
| 10/11/2006 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020832s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s016LTR.pdf | |
| 11/21/2006 | SUPPL-15 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020832s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s015ltr.pdf | |
| 06/03/2008 | SUPPL-14 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020832s014ltr.pdf |
| 10/10/2006 | SUPPL-13 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s013LTR.pdf |
| 12/08/2006 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s012ltr.pdf |
| 12/27/2005 | SUPPL-11 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020832s011,021555s005rev2.pdf |
| 04/03/2006 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s010ltr.pdf |
| 05/03/2005 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020832s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020832s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020832_S008_CHLORAPREP_WITH_TINT.pdf | |
| 07/07/2004 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20832slr007ltr.pdf |
| 06/10/2004 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20832slr006ltr.pdf |
| 08/20/2003 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20832scp004_chloraprep_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20832scp004ltr.pdf | |
| 04/26/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20832s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20832s002.pdf | |
| 11/27/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/03/2019 | SUPPL-36 | Manufacturing (CMC)-Manufacturing Process | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020832Orig1s036_REPLACEMENT_lbl.pdf | |
| 09/12/2017 | SUPPL-42 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020832Orig1s042lbl.pdf | |
| 06/30/2014 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020832Orig1s034, 021555Orig1s019lbl.pdf | |
| 10/10/2013 | SUPPL-31 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020832Orig1s031, 021555Orig1s018lbl.pdf | |
| 08/16/2012 | SUPPL-30 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Origs030, 021555Orig1s017lbl.pdf | |
| 08/16/2012 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Origs030, 021555Orig1s017lbl.pdf | |
| 08/16/2012 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Orig1s027, 020832Orig1s028, 021555Orig1s016lbl.pdf | |
| 08/16/2012 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Orig1s027, 020832Orig1s028, 021555Orig1s016lbl.pdf | |
| 05/09/2007 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020832s018lbl.pdf | |
| 11/21/2006 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020832s015lbl.pdf | |
| 10/11/2006 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020832s016lbl.pdf | |
| 05/03/2005 | SUPPL-8 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020832s008lbl.pdf | |
| 08/20/2003 | SUPPL-4 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20832scp004_chloraprep_lbl.pdf | |
| 04/26/2002 | SUPPL-2 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20832s2lbl.pdf |
CHLORAPREP ONE-STEP
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPONGE;TOPICAL; 2%;70% (3ML)
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (3ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 020832 | BECTON DICKINSON CO |
| CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (3ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 020832 | BECTON DICKINSON CO |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPONGE;TOPICAL; 2%;70% (26ML)
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (26ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 020832 | BECTON DICKINSON CO |
| CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (26ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 020832 | BECTON DICKINSON CO |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPONGE;TOPICAL; 2%;70% (1ML)
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (1ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 020832 | BECTON DICKINSON CO |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPONGE;TOPICAL; 2%;70% (10.5ML)
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (10.5ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 020832 | BECTON DICKINSON CO |
| CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (10.5ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 020832 | BECTON DICKINSON CO |
CHLORAPREP ONE-STEP FREPP
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPONGE;TOPICAL; 2%;70% (1.5ML)
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHLORAPREP ONE-STEP FREPP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (1.5ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 020832 | BECTON DICKINSON CO |
CHLORAPREP WITH TINT
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPONGE;TOPICAL; 2%;70% (3ML)
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (3ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 020832 | BECTON DICKINSON CO |
| CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (3ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 020832 | BECTON DICKINSON CO |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPONGE;TOPICAL; 2%;70% (26ML)
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (26ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 020832 | BECTON DICKINSON CO |
| CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (26ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 020832 | BECTON DICKINSON CO |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPONGE;TOPICAL; 2%;70% (10.5ML)
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHLORAPREP ONE-STEP | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (10.5ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 020832 | BECTON DICKINSON CO |
| CHLORAPREP WITH TINT | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 2%;70% (10.5ML) | SPONGE;TOPICAL | Over-the-counter | Yes | 020832 | BECTON DICKINSON CO |