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FDA Drug Application 021299 by SEBELA IRELAND LTD

Application Number021299
Application Type New Drug Application
Sponsor ApplicantSEBELA IRELAND LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA03/11/2002TA9481000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21299lbl.pdf 6/18/2004
TA03/11/2002TA9482000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21299ltr.pdf 6/18/2004
TA03/11/2002TA9483000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-299.pdf_Paroxetine%20Mesylate_Prntlbl.pdf 6/18/2004
TA03/11/2002TA9484000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-299.pdf_Paroxetine%20Mesylate_Approv.pdf 6/18/2004
TA03/11/2002TA9485000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-299_Paroxetine.cfm 6/18/2004
TA03/11/2002TA16533000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
TA03/11/2002TA24053000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088684.pdf 11/20/2009
AP17/3/2003N9481000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21299lbl.pdf 6/18/2004
AP17/3/2003N9482000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21299ltr.pdf 6/18/2004
AP17/3/2003N9483000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-299.pdf_Paroxetine%20Mesylate_Prntlbl.pdf 6/18/2004
AP17/3/2003N9484000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-299.pdf_Paroxetine%20Mesylate_Approv.pdf 6/18/2004
AP17/3/2003N9485000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-299_Paroxetine.cfm 6/18/2004
AP17/3/2003N16533000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP17/3/2003N24053000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088684.pdf 11/20/2009
AP08/21/2003SLR6565001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21299slr001ltr.pdf 8/28/2003
AP08/21/2003SLR18077001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021299_S001_PEXEVA_TABLETS.pdf 9/26/2007
AP08/30/2004SLR10098007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21299s007ltr.pdf 8/31/2004
AP01/12/2005SLR10967013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21299s013ltr.pdf 1/13/2005
AP01/12/2005SLR10987013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21299s013lbl.pdf 1/13/2005
AP012/9/2006SE115471016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021299s016,s017,s018lbl.pdf 12/14/2006
AP012/9/2006SE115556016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021299s016, s017, s018ltr.pdf 12/28/2006
AP012/9/2006SE115472017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021299s016,s017,s018lbl.pdf 12/14/2006
AP012/9/2006SE115557017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021299s016, s017, s018ltr.pdf 12/28/2006
AP012/9/2006SE115473018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021299s016,s017,s018lbl.pdf 12/14/2006
AP012/9/2006SE115558018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021299s016, s017, s018ltr.pdf 12/28/2006
AP08/3/2007SLR17502019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021299s019lbl.pdf 8/6/2007
AP08/3/2007SLR17570019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021299s019ltr.pdf 8/7/2007
AP010/5/2007SLR18193020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021299s020ltr.pdf 10/10/2007
AP010/5/2007SLR18217020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021299s020lbl.pdf 10/10/2007
AP03/6/2008SLR19390021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021299s021ltr.pdf 3/7/2008
AP03/6/2008SLR19401021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021299s021lbl.pdf 3/7/2008
AP01/29/2010SLR24708022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021299s022lbl.pdf 2/4/2010
AP01/29/2010SLR24728022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021299s022ltr.pdf 2/5/2010
AP01/30/2009SLR21722023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021299s023ltr.pdf 2/3/2009
AP01/30/2009SLR21773023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021299s023lbl.pdf 2/4/2009
AP04/28/2011SLR28627024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021299s024ltr.pdf 4/29/2011
AP04/28/2011SLR28655024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021299s024lbl.pdf 4/29/2011
AP012/18/2012SLR34720027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021299Orig1s027,s028,s029ltr.pdf 12/21/2012
AP012/18/2012SLR34721028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021299Orig1s027,s028,s029ltr.pdf 12/21/2012
AP012/18/2012SLR34722029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021299Orig1s027,s028,s029ltr.pdf 12/21/2012
AP011/26/2012SCM       
AP07/18/2014SLR39951032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021299s032lbl.pdf 7/23/2014
AP07/18/2014SLR39987032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021299Orig1s032ltr.pdf 7/24/2014




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