Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065297
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Discontinued None No No
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/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
09/18/2006 ORIG-1 Approval

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