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FDA Drug Application 020936 by APOTEX TECHNOLOGIES

Application Number020936
Application Type New Drug Application
Sponsor ApplicantAPOTEX TECHNOLOGIES
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
AP02/16/1999N3119000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-936_Paxil.cfm 2/16/1999
AP02/16/1999N649000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20936ltr.pdf 2/16/1999
AP02/16/1999N650000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20936lbl.pdf 2/16/1999
AP02/16/1999N12481000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053346.htm 8/1/2005
AP02/16/1999N34825000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM249171.pdf 1/3/2013
AP07/2/1999SCM30902001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020936Orig1s001.pdf 12/9/2011
AP08/17/2000SCM30910002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020936Orig1s002.pdf 12/9/2011
AP09/21/2000SCS30903003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020936Orig1s003.pdf 12/9/2011
AP07/18/2000SCM30907004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020936Orig1s004.pdf 12/9/2011
AP012/6/2000SCM       
AP04/30/2001SCM30913006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020936Orig1s006.pdf 12/9/2011
AP04/30/2001SCM30904007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020936Orig1s007.pdf 12/9/2011
AP02/12/2002SLR3116008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20982ltr.pdf 2/12/2002
AP02/12/2002SLR3117008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20982lbl.pdf 2/12/2002
AP02/12/2002SLR3118008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-936s008_Paroxetine_PaxilCR.cfm 2/12/2002
AP07/22/2002SCS       
AP08/28/2003SE16607011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20936se1-011_paxil_lbl.pdf 9/9/2003
AP08/28/2003SE16608011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20936se1-011ltr.pdf 9/9/2003
AP08/28/2003SE117522011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020936_S011_PAXIL CR.pdf 8/6/2007
AP010/16/2003SE117060012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020936_S012_PAXIL_AP.pdf 7/6/2007
AP010/16/2003SE16821012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20936se1-012ltr.pdf 10/17/2003
AP010/16/2003SE16828012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20936se1-012_paxil_lbl.pdf 10/17/2003
AP01/27/2004SE27639013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20936se2-013ltr.pdf 2/2/2004
AP01/27/2004SE27661013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20936se2-013_paxil_lbl.pdf 2/3/2004
AP07/13/2005SLR11994018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020031s042,020936s018ltr.pdf 7/15/2005
AP05/21/2004S8667019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20031slr043,20936slr019ltr.pdf 5/27/2004
AP01/12/2005SLR10971020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20031s045,20936s020ltr.pdf 1/13/2005
AP01/12/2005SLR10991020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20031s045,20936s020lbl.pdf 1/13/2005
AP03/9/2006SLR13805021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s021,020031s046ltr.pdf 3/23/2006
AP02/6/2006SLR13604022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s022s026s027_ltr.pdf 2/8/2006
AP08/22/2006SLR14925023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf 9/20/2006
AP02/6/2006SLR13605026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s022s026s027_ltr.pdf 2/8/2006
AP02/6/2006SLR13606027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s022s026s027_ltr.pdf 2/8/2006
AP08/2/2007SLR17597029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012342s059, 020031s053, 020710s017, 020936s029ltr.pdf 8/7/2007
AP08/2/2007SLR17491029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020936s029lbl.pdf 8/3/2007
AP08/22/2006SLR14926030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf 9/20/2006
AP08/22/2006SLR14927031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf 9/20/2006
AP07/8/2011SLR29480034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf 7/12/2011
AP07/8/2011SLR29501034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020936s034s044lbl.pdf 7/12/2011
AP08/7/2009SLR23743035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020936s035lbl.pdf 11/5/2009
AP08/7/2009SLR23984035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s059,020710s023,020936s035ltr.pdf 11/19/2009
AP010/31/2008SLR21122037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020031s060, 020936s037, 020710s024ltr.pdf 11/3/2008
AP010/31/2008SLR21151037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020031s060,020936s037,020710s024lbl.pdf 11/7/2008
AP01/30/2009SLR21733038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s061,020936s038,020710s025ltr.pdf 2/3/2009
AP01/30/2009SLR21770038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020936s038lbl.pdf 2/4/2009
AP07/17/2009SCM23992039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020936s039ltr.pdf 11/19/2009
AP03/21/2011SLR28329040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf 3/24/2011
AP03/21/2011SLR28378040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043MedG.pdf 3/28/2011
AP03/21/2011SLR28370040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf 3/28/2011
AP010/27/2010SLR26816041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020936s041lbl.pdf 10/28/2010
AP010/27/2010SLR26855041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020031s063,020710s027,020936s041ltr.pdf 11/2/2010
AP03/21/2011SLR28330043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf 3/24/2011
AP03/21/2011SLR28371043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf 3/28/2011
AP07/8/2011SLR29502044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020936s034s044lbl.pdf 7/12/2011
AP07/8/2011SLR29481044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf 7/12/2011
AP012/18/2012SLR34717045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031Orig1s067,020710Orig1s031,020936Orig1s045ltr.pdf 12/21/2012
AP012/18/2012SLR34802045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020936s045lbl.pdf 12/31/2012
AP04/10/2012SLR32412046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031s068,020710s032,020936s046ltr.pdf 4/12/2012
AP04/10/2012SLR32445046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020936s046lbl.pdf 4/17/2012
AP07/18/2014SLR39939049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020031Orig1s071,020710Orig1s035,020936Orig1s049ltr.pdf 7/23/2014
AP07/18/2014SLR40061049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020936s049lbl.pdf 7/30/2014




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