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FDA Drug Application 011366 by TARO

Application Number011366
Application Type New Drug Application
Sponsor ApplicantTARO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/22/1958N       
AP07/28/1978SCS       
AP012/20/1979SLR       
AP012/18/1979SLR       
AP011/5/1986SPD       
AP02/26/1982SCS       
AP08/6/1984SCS       
AP09/6/1985SCS       
AP09/6/1985SLR       
AP02/12/1991SCS       
AP06/2/1989SCM       
AP06/13/1995SCS       
AP010/24/1994SLR       
AP03/16/2012SCS32156028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/011366s028ltr.pdf 3/19/2012
AP012/19/2013SCM       
AP08/7/2015SE843607030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011366s030lbl.pdf 8/10/2015
AP08/7/2015SE843608030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011366Orig1s030ltr.pdf 8/10/2015




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