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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018300
Company: MOLNLYCKE HLTH

Products on NDA 018300

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018300

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.

Labels for NDA 018300

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

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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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