Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205666
Company: AMNEAL PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN 100MG/5ML SUSPENSION;ORAL None (Tentative Approval) None No No
AZITHROMYCIN AZITHROMYCIN 200MG/5ML SUSPENSION;ORAL None (Tentative Approval) 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
03/17/2017 ORIG-1 Tentative Approval STANDARD

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