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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021669
Company: SAGE PRODS

Products on NDA 021669

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021669

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.

Labels for NDA 021669

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

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

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

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