Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019422
Company: XTTRIUM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EXIDINE CHLORHEXIDINE GLUCONATE 2% SOLUTION;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
12/17/1985 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
01/25/2019 SUPPL-49 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019422Orig1s049Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019422Orig1s049ltr.pdf
09/15/2017 SUPPL-47 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019422Orig1s047ltr.pdf
04/11/2016 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

03/24/2016 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

12/12/2012 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019422Orig1s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019422Orig1s043ltr.pdf
02/25/2009 SUPPL-37 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019422s037ltr.pdf
02/25/2009 SUPPL-36 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019422s036ltr.pdf
12/20/2004 SUPPL-33 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/019422s033ltr.pdf
12/19/2003 SUPPL-32 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19422se8-032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019422_S032_ChlorhexidineTOC.cfm
10/08/1999 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/29/2000 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/19/1998 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1998 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/08/1998 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1997 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/11/1997 SUPPL-23 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/06/1996 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/03/1996 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1996 SUPPL-20 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/06/1996 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/06/1996 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/10/1995 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/06/1992 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/28/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/12/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/28/1988 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/1988 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/16/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/16/1987 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/02/1988 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/27/1989 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/25/2019 SUPPL-49 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019422Orig1s049Lbl.pdf
12/12/2012 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019422Orig1s043lbl.pdf

EXIDINE

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

SOLUTION;TOPICAL; 2%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CIDA-STAT CHLORHEXIDINE GLUCONATE 2% SOLUTION;TOPICAL Over-the-counter No 019258 ECOLAB
EXIDINE CHLORHEXIDINE GLUCONATE 2% SOLUTION;TOPICAL Over-the-counter Yes 019422 XTTRIUM

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