Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203412
Company: HAINAN POLY PHARMA CO LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN 500MG INJECTABLE;INJECTION 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
10/19/2015 ORIG-1 Tentative Approval Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203412Orig1s000TAltr.pdf

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