An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020832
Company: BECTON DICKINSON CO

General Correspondence

Products on NDA 20832

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

Labels for NDA 020832

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

Top