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FDA Drug Application 089699 by MIKART

Application Number089699
Application Type Abbreviated New Drug Application
Sponsor ApplicantMIKART
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/25/1989N       
AP06/21/1991SC       
AP06/21/1991SC       
AP06/21/1991SC       
AP07/11/1991SC       
AP07/11/1991SC       
AP01/21/1992SC       
AP02/25/1993SC       
AP06/30/1993SC       
AP02/25/1993SC       
AP01/29/1997SL       
AP02/8/1995SC       
AP07/19/1995SC       
AP08/31/2000SC       
AP08/31/2000SC       
AP08/31/2000SC       
AP08/31/2000SC       
AP09/18/1996SC       
AP09/18/1996SC       
AP07/31/1998SC       
AP09/9/1998SC       
AP08/13/2002SCB       
AP011/20/2002SL       
AP010/18/2013SLR44243044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040432s006,040556s012,040658s006,040846s005,089699s044ltr.pdf 10/22/2015
AP010/18/2013SLR44312044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf 10/27/2015




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