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FDA Drug Application 020392 by MYLAN

Application Number020392
Application Type New Drug Application
Sponsor ApplicantMYLAN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/15/1994N       
AP011/28/1995SCS       
AP08/16/1996SLR       
AP02/12/1998SCS       
AP03/5/1999SCP       
AP04/6/2001SLR5022005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20392S5ltr.pdf 4/11/2001
AP01/30/2004SLR7673007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20392slr007ltr.pdf 2/3/2004
AP06/6/2007SLR16721010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020392s010lbl.pdf 6/7/2007
AP06/6/2007SLR16769010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020392s010ltr.pdf 6/14/2007
AP06/15/2015SCM       
AP06/6/2016SCM       




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