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FDA Drug Application 020950 by MYLAN SPECLT

Application Number020950
Application Type New Drug Application
Sponsor ApplicantMYLAN SPECLT
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/21/2001N4682000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb_Approv.pdf 3/21/2001
AP03/21/2001N4683000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb_prntlbl.pdf 3/21/2001
AP03/21/2001N4684000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb.cfm 3/21/2001
AP06/18/2001SCS       
AP09/5/2001SCS       
AP08/31/2001SCS       
AP02/20/2002SCS       
AP02/20/2002SCS       
AP07/12/2002SCM       
AP010/28/2002SCS       
AP012/10/2002SCP       
AP06/2/2006SLR14232012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020950s012PI.pdf 6/6/2006
AP06/2/2006SLR14242012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020950s012LTR.pdf 6/6/2006
AP09/26/2005SCS12935018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020950s018ltr.pdf 10/20/2005
AP03/3/2011SLR28106032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020950s032ltr.pdf 3/7/2011
AP03/3/2011SLR28147032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020950s032lbl.pdf 3/7/2011
AP05/29/2012SLR32782037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020950s037ltr.pdf 5/31/2012
AP05/29/2012SLR32833037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020950s037lbl.pdf 6/6/2012
AP010/18/2013SCM       




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