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FDA Drug Application 022067 by TARO

Application Number022067
Application Type New Drug Application
Sponsor ApplicantTARO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/17/2008N18887000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067lbl.pdf 1/18/2008
AP01/17/2008N18933000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022067s000ltr.pdf 1/23/2008
AP01/17/2008N24840000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022067_flo-pred_toc.cfm 2/24/2010
AP01/17/2008N24841000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022067s000sumr.pdf 2/24/2010
AP06/27/2008SCP20114001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067s001lbl.pdf 6/30/2008
AP06/27/2008SCP20145001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022067s001ltr.pdf 7/1/2008
AP010/3/2008SCP20972002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022067s002ltr.pdf 10/8/2008
AP010/3/2008SCP21010002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067s002lbl.pdf 10/9/2008
AP05/6/2010SCM25529004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022067s004ltr.pdf 5/12/2010
AP05/6/2010SCM25576004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022067s004lbl.pdf 5/17/2010
AP06/14/2011SLR29171007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022067s007lbl.pdf 6/16/2011
AP06/14/2011SLR29228007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022067s007ltr.pdf 6/17/2011
AP02/28/2014SCM       
AP09/29/2014SCM       
AP010/3/2014SCM       




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