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FDA Drug Application 020031 by APOTEX TECHNOLOGIES

Application Number020031
Application Type New Drug Application
Sponsor ApplicantAPOTEX TECHNOLOGIES
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/29/1992N12616000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053346.htm 8/16/2005
AP012/29/1992N24048000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088676.pdf 11/20/2009
AP011/29/1994SCS       
AP06/22/1994SCE       
AP02/23/1995SLR       
AP09/22/1994SCF       
AP02/23/1995SLR       
AP05/10/1995SCM       
AP05/7/1996SE1       
AP02/23/1995SLR       
AP05/7/1996SE1       
AP03/5/1996SCS       
AP07/2/1996SCS       
AP07/11/1996SCS       
AP06/24/1997SCF       
AP010/17/1996SLR       
AP012/13/1996SCS       
AP05/19/1997SLR       
AP07/14/1997SCS       
AP07/22/1997SCS       
AP012/16/1997SCM       
AP02/19/1998SCS       
AP02/19/1998SCS       
AP05/11/1999SE1889023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20031s23ltr.pdf 5/11/1999
AP05/11/1999SE15448023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031s23lbl.pdf 4/24/2003
AP05/17/2000SCM17164025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S025_PAXIL_AP.pdf 7/9/2007
AP04/13/2001SE11556026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20031S26ltr.pdf 4/13/2001
AP04/13/2001SE11557026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031S26lbl.pdf 4/13/2001
AP04/13/2001SE19590026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-031S026_Paxil.cfm 6/29/2004
AP09/20/2000SCM17163027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S027_PAXIL_AP.pdf 7/9/2007
AP09/21/2000SCS17162028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S028_PAXIL_AP.pdf 7/9/2007
AP012/14/2001SE13121029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20031s29ltr.pdf 12/14/2001
AP012/14/2001SE13122029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031s29lbl.pdf 12/14/2001
AP012/14/2001SE110186029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-031S029.pdf 9/15/2004
AP09/28/2000SLR17157030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S030_PAXIL_AP.pdf 7/9/2007
AP02/15/2001SLR17156031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020031_S031_PAXIL_AP.pdf 7/9/2007
AP04/30/2001SCM       
AP05/22/2001SCP       
AP04/30/2001SCM       
AP010/2/2002SE83120035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20031se8-035ltr.pdf 10/2/2002
AP04/8/2004SLR8376039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20031slr039,040ltr.pdf 4/20/2004
AP04/8/2004SLR8377040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20031slr039,040ltr.pdf 4/20/2004
AP07/13/2005SLR11995042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020031s042,020936s018ltr.pdf 7/15/2005
AP05/21/2004S8666043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20031slr043,20936slr019ltr.pdf 5/27/2004
AP01/12/2005SLR10970045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20031s045,20936s020ltr.pdf 1/13/2005
AP01/12/2005SLR10990045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20031s045,20936s020lbl.pdf 1/13/2005
AP03/9/2006SLR13804046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s021,020031s046ltr.pdf 3/23/2006
AP02/6/2006SLR13607048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020031s048s051s052ltr.pdf 2/8/2006
AP08/22/2006SLR14963049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf 9/25/2006
AP02/6/2006SLR13608051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020031s048s051s052ltr.pdf 2/8/2006
AP02/6/2006SLR13609052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020031s048s051s052ltr.pdf 2/8/2006
AP02/6/2006SLR38295052   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020031Orig1s052.pdf 1/16/2014
AP08/2/2007SLR17490053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020031s053,020710s017lbl.pdf 8/3/2007
AP08/2/2007SLR17599053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012342s059, 020031s053, 020710s017, 020936s029ltr.pdf 8/7/2007
AP08/22/2006SLR14964054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf 9/25/2006
AP08/22/2006SLR14965055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf 9/25/2006
AP07/8/2011SLR29476058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf 7/12/2011
AP07/8/2011SLR29499058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf 7/12/2011
AP08/7/2009SLR23741059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s05920710s023lbl.pdf 11/5/2009
AP08/7/2009SLR23982059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s059,020710s023,020936s035ltr.pdf 11/19/2009
AP010/31/2008SLR21121060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020031s060, 020936s037, 020710s024ltr.pdf 11/3/2008
AP010/31/2008SLR21152060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020031s060,020936s037,020710s024lbl.pdf 11/7/2008
AP01/30/2009SLR21732061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s061,020936s038,020710s025ltr.pdf 2/3/2009
AP01/30/2009SLR21757061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s061,020710s025lbl.pdf 2/4/2009
AP03/21/2011SLR28323062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf 3/24/2011
AP03/21/2011SLR28372062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf 3/28/2011
AP010/27/2010SLR26818063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020031s063,020710s027lbl.pdf 10/28/2010
AP010/27/2010SLR26853063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020031s063,020710s027,020936s041ltr.pdf 11/2/2010
AP03/21/2011SLR28324065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf 3/24/2011
AP03/21/2011SLR28373065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf 3/28/2011
AP07/8/2011SLR29477066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf 7/12/2011
AP07/8/2011SLR29500066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf 7/12/2011
AP012/18/2012SLR34715067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031Orig1s067,020710Orig1s031,020936Orig1s045ltr.pdf 12/21/2012
AP012/18/2012SLR34803067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s067,020710s031.pdf 12/31/2012
AP04/10/2012SLR32410068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031s068,020710s032,020936s046ltr.pdf 4/12/2012
AP04/10/2012SLR32447068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s068,20710s032lbl.pdf 4/17/2012
AP03/21/2011SLR28325069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf 3/24/2011
AP03/21/2011SLR28374069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf 3/28/2011
AP07/18/2014SLR39937071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020031Orig1s071,020710Orig1s035,020936Orig1s049ltr.pdf 7/23/2014
AP07/18/2014SLR40058071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020031s071,020710s035lbl.pdf 7/29/2014




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