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FDA Drug Application 019832 by MYLAN INSTITUTIONAL

Application Number019832
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
AP06/5/1998N10000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19832ltr.pdf 6/5/1998
AP06/5/1998N11000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19832.cfm 1/6/1999
AP06/5/1998N12000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19832lbl.pdf 6/5/1998
AP09/25/1998SCS       
AP07/12/2001SLR3327002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19832s2s3ltr.pdf 7/12/2001
AP07/12/2001SCS3328003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19832s2s3ltr.pdf 7/12/2001
AP09/17/2001SCS       
AP05/9/2002SCS       
AP012/18/2002SCS       
AP06/18/2013SCM       
AP01/20/2015SCM       




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