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FDA Drug Application 022294 by AUROBINDO PHARMA

Application Number022294
Application Type New Drug Application
Sponsor ApplicantAUROBINDO PHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/23/2009N23093000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022294lbl.pdf 7/30/2009
AP07/23/2009N23101000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022294s000ltr.pdf 7/31/2009
AP07/23/2009N23809000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022294_zidovudine_toc.cfm 11/10/2009
AP07/23/2009N23810000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022294s000_SumR.pdf 11/10/2009
AP012/30/2010SCM27437002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022294s002lbl.pdf 1/4/2011
AP012/30/2010SCM27453002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022294s002ltr.pdf 1/5/2011
AP07/31/2013SCM       




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