Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018300
Company: MOLNLYCKE HLTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HIBISTAT CHLORHEXIDINE GLUCONATE 0.5% 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
05/23/1980 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
04/19/2018 SUPPL-19 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018300Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018300Orig1s019ltr.pdf
05/24/2012 SUPPL-18 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018300s018ltr.pdf
01/13/2004 SUPPL-15 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18300scm015ltr.pdf
01/13/2004 SUPPL-14 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18300scm014ltr.pdf
02/18/2000 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/19/1999 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/09/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/14/1994 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/22/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/15/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/09/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/04/1989 SUPPL-6 Labeling

Label is not available on this site.

03/04/1985 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/10/1981 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1981 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/29/1980 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1980 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/19/2018 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018300Orig1s019lbl.pdf

HIBISTAT

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

SOLUTION;TOPICAL; 0.5%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
HIBISTAT CHLORHEXIDINE GLUCONATE 0.5% SOLUTION;TOPICAL Over-the-counter Yes 018300 MOLNLYCKE HLTH

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