Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018423
Company: MOLNLYCKE HLTH

Products on NDA 018423

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HIBICLENS	CHLORHEXIDINE GLUCONATE	4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SPONGE;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018423

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/27/1981	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
12/12/2001	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
10/19/1999	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/23/1992	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
07/14/1989	SUPPL-12	Manufacturing (CMC)-Formulation		Label is not available on this site.
09/15/1989	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
08/25/1989	SUPPL-10	Labeling		Label is not available on this site.
07/05/1988	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
06/22/1988	SUPPL-7	Labeling		Label is not available on this site.
12/10/1987	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/02/1988	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
02/22/1986	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
11/18/1983	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
10/19/1981	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.