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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019127
Company: XTTRIUM

Products on NDA 019127

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EXIDINE	CHLORHEXIDINE GLUCONATE	4%	AEROSOL, METERED;TOPICAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019127

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/24/1984	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/14/2017	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019127Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019127Orig1s022ltr.pdf
04/11/2013	SUPPL-20	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019127Orig1s020ltr.pdf
07/11/2012	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
06/16/2009	SUPPL-13	Labeling-Package Insert, Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019127s013ltr.pdf
06/30/1997	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
04/12/1996	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
02/13/1996	SUPPL-8	Manufacturing (CMC)-Formulation		Label is not available on this site.
06/19/1995	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
06/19/1995	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/15/1994	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/28/1988	SUPPL-2	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
03/02/1988	SUPPL-1	Manufacturing (CMC)-Expiration Date		Label is not available on this site.

Labels for NDA 019127

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/14/2017	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019127Orig1s022lbl.pdf

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

EXIDINE

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

AEROSOL, METERED;TOPICAL; 4%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
EXIDINE	CHLORHEXIDINE GLUCONATE	4%	AEROSOL, METERED;TOPICAL	Over-the-counter	Yes	019127	XTTRIUM

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