Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091644
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOFLOXACIN LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE;INJECTION Discontinued None No No
LEVOFLOXACIN LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE;INJECTION 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
06/20/2011 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
08/13/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

08/13/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

01/03/2012 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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