Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065265
Company: CSPC OUYI PHARM CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION 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
01/18/2007 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
10/07/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/03/2013 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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