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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065366
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;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
05/30/2007 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
05/18/2020 SUPPL-10 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

05/18/2020 SUPPL-9 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

04/09/2015 SUPPL-8 Labeling-Patient Package Insert

Label is not available on this site.

08/25/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

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