Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017768
Company: MOLNLYCKE HLTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HIBICLENS CHLORHEXIDINE GLUCONATE 4% 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
09/17/1976 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2018 SUPPL-49 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017768Orig1s049lbl.pdf
08/10/2018 SUPPL-48 Labeling-Package Insert

Label is not available on this site.

10/17/2017 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017768Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017768Orig1s044ltr.pdf
12/09/2015 SUPPL-42 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017768s042lbl.pdf
06/30/2014 SUPPL-41 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017768Orig1s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017768Orig1s041ltr.pdf
05/24/2012 SUPPL-39 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017768s039ltr.pdf
07/02/2002 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

12/12/2001 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/23/2000 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/20/1999 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/30/1998 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1994 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/14/1989 SUPPL-27 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/18/1989 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1989 SUPPL-25 Labeling

Label is not available on this site.

05/11/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/03/1988 SUPPL-23 Labeling

Label is not available on this site.

04/06/1987 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/09/1985 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1984 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/21/1981 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1981 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1981 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/29/1980 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1987 SUPPL-11 Labeling

Label is not available on this site.

07/30/1980 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/25/1979 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/18/1979 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/18/1979 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/06/1981 SUPPL-5 Labeling

Label is not available on this site.

05/12/1978 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/06/1978 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/01/1982 SUPPL-2 Efficacy

Label is not available on this site.

05/09/1977 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/30/2018 SUPPL-49 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017768Orig1s049lbl.pdf
10/17/2017 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017768Orig1s044lbl.pdf
12/09/2015 SUPPL-42 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017768s042lbl.pdf
06/30/2014 SUPPL-41 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017768Orig1s041lbl.pdf

HIBICLENS

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

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