Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018423
Company: MOLNLYCKE HLTH
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HIBICLENS CHLORHEXIDINE GLUCONATE 4% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SPONGE;TOPICAL Discontinued None Yes No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
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.

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