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FDA Drug Application 020630 by MYLAN INSTITUTIONAL

Application Number020630
Application Type New Drug Application
Sponsor ApplicantMYLAN INSTITUTIONAL
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
AP07/12/1996N       
AP010/15/1999SE5       
AP011/23/1999SE8       
AP06/23/1999SLR       
AP03/8/2004SE57856005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20630se5-005ltr.pdf 3/10/2004
AP03/8/2004SE58251005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20630se5-005_ultiva_lbl.pdf 4/5/2004
AP09/19/2000SCS       
AP011/19/2001SCM       
AP012/20/2002SCM       
AP010/3/2002SCM       
AP06/11/2013SCM       
AP01/12/2016SCM       




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