Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 021555
Company: BECTON DICKINSON CO

Products on NDA 021555

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORAPREP ONE-STEP SEPP	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	2%;70% (0.67ML)	SWAB;TOPICAL	Over-the-counter	None	Yes	Yes
CHLORAPREP SINGLE SWABSTICK	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	2%;70% (1.75ML)	SWAB;TOPICAL	Over-the-counter	None	Yes	Yes
CHLORAPREP TRIPLE SWABSTICK	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	2%;70% (5.25ML)	SWAB;TOPICAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021555

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/07/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21555lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21555ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-555_Chloraprep.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/30/2023	SUPPL-28	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021555Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021555Orig1s028ltr.pdf
09/12/2017	SUPPL-24	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/21555Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/21555Orig1s024ltr.pdf
12/22/2017	SUPPL-20	Manufacturing (CMC)-Control	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021555Origs020lbl.pdf
06/30/2014	SUPPL-19	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
10/10/2013	SUPPL-18	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-17	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
08/16/2012	SUPPL-16	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-15	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021555s015ltr.pdf
03/02/2010	SUPPL-14	Labeling-Container/Carton Labels		Label is not available on this site.
08/09/2007	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021555s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021555s009ltr.pdf
12/20/2006	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021555s007ltr.pdf
12/27/2005	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020832s011,021555s005rev2.pdf
06/10/2009	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021555s003ltr.pdf
05/10/2005	SUPPL-1	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021555s001ltr.pdf

Labels for NDA 021555

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/30/2023	SUPPL-28	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021555Orig1s028lbl.pdf
12/22/2017	SUPPL-20	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021555Origs020lbl.pdf
09/12/2017	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/21555Orig1s024lbl.pdf
09/12/2017	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/21555Orig1s024lbl.pdf
06/30/2014	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020832Orig1s034, 021555Orig1s019lbl.pdf
10/10/2013	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020832Orig1s031, 021555Orig1s018lbl.pdf
08/16/2012	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Origs030, 021555Orig1s017lbl.pdf
08/16/2012	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Origs030, 021555Orig1s017lbl.pdf
08/16/2012	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Orig1s027, 020832Orig1s028, 021555Orig1s016lbl.pdf
08/09/2007	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021555s009lbl.pdf
08/09/2007	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021555s009lbl.pdf
10/07/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21555lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

CHLORAPREP ONE-STEP SEPP

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SWAB;TOPICAL; 2%;70% (0.67ML)

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CHLORAPREP ONE-STEP SEPP	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	2%;70% (0.67ML)	SWAB;TOPICAL	Over-the-counter	Yes	021555	BECTON DICKINSON CO

CHLORAPREP SINGLE SWABSTICK

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SWAB;TOPICAL; 2%;70% (1.75ML)

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CHLORAPREP SINGLE SWABSTICK	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	2%;70% (1.75ML)	SWAB;TOPICAL	Over-the-counter	Yes	021555	BECTON DICKINSON CO

CHLORAPREP TRIPLE SWABSTICK

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SWAB;TOPICAL; 2%;70% (5.25ML)

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CHLORAPREP TRIPLE SWABSTICK	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	2%;70% (5.25ML)	SWAB;TOPICAL	Over-the-counter	Yes	021555	BECTON DICKINSON CO