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FDA Drug Application 050719 by SEBELA IRELAND LTD

Application Number050719
Application Type New Drug Application
Sponsor ApplicantSEBELA IRELAND LTD
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
AP08/15/1996N9053000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50719slr06ltr.pdf 6/7/2004
AP08/28/1997SLR       
AP05/15/1998SCS       
AP010/30/1998SCM       
AP07/29/1999SCM       
AP06/30/1999SLR       
AP012/12/2002SLR2205006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50719slr006_Helidac_lbl.pdf 12/12/2002
AP012/12/2002SLR9054006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50719slr06ltr.pdf 6/7/2004
AP04/27/2003SLR5574007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050719s007lbl.pdf 5/6/2003
AP04/27/2003SLR5733007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50719slr007ltr.pdf 5/29/2003
AP09/10/2004SLR10189008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50719s008lbl.pdf 9/15/2004
AP09/10/2004SLR10190008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50719s008ltr.pdf 9/15/2004
AP07/24/2007SLR17393009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050719s009ltr.pdf 7/27/2007
AP06/27/2008SLR20117013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050719s013lbl.pdf 6/30/2008
AP06/27/2008SLR20148013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050719s013ltr.pdf 7/1/2008
AP011/12/2009SLR23900015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050719s015lbl.pdf 11/16/2009
AP011/12/2009SLR24579015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050719s015ltr.pdf 1/21/2010
AP06/19/2012SLR33006017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050719s017s020lbl.pdf 6/26/2012
AP06/19/2012SCM32947020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050719s017s020lbl.pdf 6/20/2012
AP08/11/2015SLR43637021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050719s021lbl.pdf 8/12/2015
AP08/11/2015SLR43842021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050719Orig1s021ltr.pdf 9/10/2015




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