CHG SCRUB از شرکت ECOLAB

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CHG SCRUB از شرکت ECOLAB

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
BRIAN CARE CHLORHEXIDINE GLUCONATE 4% SOLUTION;TOPICAL Over-the-counter No 071419 SOAPCO
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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