Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022294
Company: AUROBINDO PHARMA

• Summary Review

Products on NDA 022294

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZIDOVUDINE	ZIDOVUDINE	60MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022294

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

Labels for NDA 022294

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