Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065129
Company: LUPIN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUPRAX CEFIXIME 100MG/5ML FOR SUSPENSION;ORAL 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
02/23/2004 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
06/04/2018 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

06/13/2016 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

03/29/2013 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

02/25/2009 SUPPL-9 Labeling

Label is not available on this site.

10/06/2005 SUPPL-7 Labeling

Label is not available on this site.

12/09/2004 SUPPL-3 Labeling

Label is not available on this site.

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