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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019125
Company: XTTRIUM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EXIDINE CHLORHEXIDINE GLUCONATE 4% SOLUTION;TOPICAL Over-the-counter None No No

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
09/29/2022 SUPPL-45 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019125Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019125Orig1s045ltr.pdf
09/14/2017 SUPPL-44 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019125Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019125Orig1s044ltr.pdf
10/17/2014 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019125Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019125Orig1s042ltr.pdf
11/09/2012 SUPPL-40 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019125Orig1s040ltr.pdf
05/16/2005 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019125s034ltr.pdf
10/08/1999 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/08/1999 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.
09/11/1998 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.
06/06/1996 SUPPL-28 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/19-125S028.pdf
05/06/1996 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/12/1996 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
02/21/1996 SUPPL-25 Manufacturing (CMC)-Formulation

Label is not available on this site.
02/06/1996 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.
02/06/1996 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
08/28/1995 SUPPL-21 Manufacturing (CMC)-Formulation

Label is not available on this site.
05/10/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
05/10/1995 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.
11/06/1992 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/07/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
01/23/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
08/14/1989 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.
08/25/1988 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
12/27/1989 SUPPL-4 Efficacy-New Indication

Label is not available on this site.
09/04/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
06/09/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
09/29/2022 SUPPL-45 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019125Orig1s045lbl.pdf
09/14/2017 SUPPL-44 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019125Orig1s044lbl.pdf
10/17/2014 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019125Orig1s042lbl.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; 4%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHG SCRUB CHLORHEXIDINE GLUCONATE 4% SOLUTION;TOPICAL Over-the-counter No 019258 ECOLAB
EXIDINE CHLORHEXIDINE GLUCONATE 4% SOLUTION;TOPICAL Over-the-counter No 019125 XTTRIUM
HIBICLENS CHLORHEXIDINE GLUCONATE 4% SOLUTION;TOPICAL Over-the-counter Yes 017768 MOLNLYCKE HLTH
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