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FDA Drug Application 020313 by MYLAN IRELAND LTD

Application Number020313
Application Type New Drug Application
Sponsor ApplicantMYLAN IRELAND LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/17/1995N38764000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm388640.htm 3/12/2014
AP010/22/1996SLR       
AP03/7/1997SLR       
AP012/24/1998SCP       
AP03/27/1997SCS       
AP04/24/1997SCS       
AP08/1/1997SCS       
AP09/15/1997SCS       
AP01/12/1998SLR       
AP08/14/1998SCM       
AP012/17/1998SCM       
AP01/13/1999SCM       
AP07/23/1999SCS       
AP07/14/2000SCS       
AP011/2/2001SCM       
AP05/10/2002SCS       
AP01/6/2006SLR13441021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020313s021ltr.pdf 1/20/2006
AP08/22/2003SCS17040023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020313_S023_MIACALCIN_AP.pdf 7/6/2007
AP08/22/2003SCS6548023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20313scs023ltr.pdf 8/28/2003
AP010/30/2009SLR24232029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020313s029lbl.pdf 12/10/2009
AP04/18/2012SLR32488033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020313s033lbl.pdf 4/20/2012
AP04/18/2012SLR32497033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020313s033ltr.pdf 4/23/2012
AP03/11/2014SLR38768034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020313s034lbl.pdf 3/13/2014
AP03/11/2014SLR38769034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020313Orig1s034ltr.pdf 3/13/2014
AP02/27/2014SCM       




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