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FDA Drug Application 020615 by MYLAN INSTITUTIONAL

Application Number020615
Application Type New Drug Application
Sponsor ApplicantMYLAN INSTITUTIONAL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/2/1996N3734000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020615ap.pdf 11/4/1996
AP04/27/1999SCP       
AP04/24/2009SLR22390002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020615s002ltr.pdf 5/4/2009
AP04/24/2009SLR22560002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020615s002lbl.pdf 5/13/2009
AP07/28/2010SLR26086003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020615s003ltr.pdf 8/2/2010
AP07/28/2010SLR26155003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020615s003lbl.pdf 8/9/2010
AP01/11/2013SCM       
AP03/12/2013SCM       
AP08/1/2016SCM       




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