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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019258
Company: ECOLAB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHG SCRUB CHLORHEXIDINE GLUCONATE 4% SOLUTION;TOPICAL Over-the-counter None No No
CIDA-STAT CHLORHEXIDINE GLUCONATE 2% 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
07/22/1986 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
01/10/2018 SUPPL-26 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019258Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019258Orig1s026ltr.pdf
01/14/2016 SUPPL-23 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019258Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019258Orig1s023ltr.pdf
12/28/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/05/2015 SUPPL-21 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019258Orig1s021ltr.pdf
12/16/2014 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/17/2012 SUPPL-19 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019258s019ltr.pdf
04/23/2010 SUPPL-16 Labeling-Proprietary Name Change Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019258s016ltr.pdf
04/03/2006 SUPPL-14 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019258s014ltr.pdf
12/20/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/2002 SUPPL-12 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/15/2005 SUPPL-11 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19258s011ltr.pdf
04/17/2001 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/16/1995 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1995 SUPPL-8 Labeling

Label is not available on this site.

05/06/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/10/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/02/1987 SUPPL-2 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
01/10/2018 SUPPL-26 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019258Orig1s026lbl.pdf
01/14/2016 SUPPL-23 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019258Orig1s023lbl.pdf

CHG SCRUB

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

CIDA-STAT

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
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