Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022294
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZIDOVUDINE ZIDOVUDINE 60MG TABLET;ORAL 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
07/23/2009 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022294lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022294s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022294_zidovudine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022294s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/31/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/30/2010 SUPPL-2 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022294s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022294s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/30/2010 SUPPL-2 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022294s002lbl.pdf
07/23/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022294lbl.pdf

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