Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207531
Company: EPIC PHARMA
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
05/26/2017 ORIG-1 Tentative Approval STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207531Orig1s000TAltr.pdf

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