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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074356
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 0.12% SOLUTION;DENTAL Discontinued None No 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
05/07/1996 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/20/2020 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

02/27/2020 SUPPL-12 Labeling-Container/Carton Labels

Label is not available on this site.

06/30/2010 SUPPL-5 Labeling

Label is not available on this site.

08/24/2009 SUPPL-4 Labeling

Label is not available on this site.

10/24/2003 SUPPL-2 Labeling

Label is not available on this site.

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