Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050809
Company: TEVA PARENTERAL
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
AZITHROMYCIN AZITHROMYCIN EQ 2.5GM 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
12/19/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050809lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050809s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050809_azithromycin_toc.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050809lbl.pdf

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