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FDA Drug Application 018594 by TARO PHARMS NORTH

Application Number018594
Application Type New Drug Application
Sponsor ApplicantTARO PHARMS NORTH
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
AP01/17/1985N       
AP02/19/1988SCM       
AP011/8/1988SCS       
AP010/13/1993SCS       
AP07/26/1994SCM       
AP05/14/2010SLR25588007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018594s007ltr.pdf 5/21/2010
AP05/14/2010SLR25640007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018594s007lbl.pdf 5/28/2010
AP012/7/2012SCM41217008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018594Orig1s008ltr.pdf 12/11/2014
AP012/7/2012SCM41317008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018594Orig1s008lbl.pdf 12/19/2014
AP05/12/2014SCM       
AP011/26/2014SCM       
AP011/26/2014SCM       
AP011/6/2015SCM       




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