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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065360
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 600MG 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
01/08/2007 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
11/22/2021 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

11/15/2021 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

06/11/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

02/10/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

08/09/2014 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

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