Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021669
Company: SAGE PRODS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 2% CLOTH;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
04/25/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021669lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021669ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21669s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/06/2017 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021669Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021669Orig1s023ltr.pdf
06/07/2016 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/16/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/24/2014 SUPPL-19 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021669Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021669Orig1s019ltr.pdf
11/22/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/30/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/26/2012 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/20/2012 SUPPL-14 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021669s014ltr.pdf
02/01/2007 SUPPL-6 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021669_s006_chlorhexidine gluconate.pdf
07/24/2006 SUPPL-4

Label is not available on this site.

08/17/2006 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021669s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021669s003LTR.pdf
01/13/2006 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021669s002ltr.pdf
02/17/2006 SUPPL-1

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/06/2017 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021669Orig1s023lbl.pdf
06/24/2014 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021669Orig1s019lbl.pdf
08/17/2006 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021669s003lbl.pdf
04/25/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021669lbl.pdf

CHLORHEXIDINE GLUCONATE

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

CLOTH;TOPICAL; 2%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 2% CLOTH;TOPICAL Over-the-counter Yes 021669 SAGE PRODS
READYPREP CHG CHLORHEXIDINE GLUCONATE 2% CLOTH;TOPICAL Over-the-counter No 207964 MEDLINE INDUSTRIES

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English