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FDA Drug Application 017808 by MYLAN IRELAND LTD

Application Number017808
Application Type New Drug Application
Sponsor ApplicantMYLAN IRELAND LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/3/1986N38763000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm388640.htm 3/12/2014
AP03/29/1991SCF       
AP010/3/1991SLR       
AP03/26/1993SLR       
AP06/26/1992SCM       
AP07/22/1994SCS       
AP06/10/1992SLR       
AP06/1/1992SLR       
AP02/22/1993SCS       
AP08/5/1992SCP       
AP06/9/1995SCS       
AP08/14/1996SCM       
AP01/2/1997SCM       
AP08/1/1997SCS       
AP07/14/1997SLR4306014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/017808a_s014.pdf 7/14/1997
AP012/24/1998SCM       
AP01/13/1999SCM       
AP05/26/1999SCM       
AP07/23/1999SCS       
AP011/2/2001SCM       
AP02/12/2002SCM       
AP06/3/2003SLR5787024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17808slr024ltr.pdf 6/8/2003
AP010/30/2009SLR24233030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017808s030lbl.pdf 12/10/2009
AP02/19/2013SCM       
AP04/18/2012SLR32489034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017808s034lbl.pdf 4/20/2012
AP04/18/2012SLR32496034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017808s034ltr.pdf 4/23/2012
AP03/11/2014SLR38766035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017808s035lbl.pdf 3/13/2014
AP03/11/2014SLR38767035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017808Orig1s035ltr.pdf 3/13/2014
AP02/2/2015SLR41765036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017808Orig1s036ltr.pdf 2/3/2015
AP02/2/2015SLR41774036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017808s036lbl.pdf 2/3/2015




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