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FDA Drug Application 020710 by APOTEX TECHNOLOGIES

Application Number020710
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
AP06/25/1997N12479000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053346.htm 8/1/2005
AP06/25/1997N24049000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088676.pdf 11/20/2009
AP011/6/1997SCS17927001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/020710_S001_PAXIL_TABLETS.pdf 9/24/2007
AP02/20/1998SCS17926002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020710_S002_PAXIL_TABLETS.pdf 9/24/2007
AP02/23/1999SCS17925004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020710_S004_PAXIL_TABLETS.pdf 9/24/2007
AP06/27/2000SCM       
AP09/21/2000SCS       
AP07/18/2000SCM30909007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020710Orig1s007.pdf 12/9/2011
AP09/28/2000SLR       
AP02/15/2001SLR       
AP04/30/2001SCM30911010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020710Orig1s010.pdf 12/9/2011
AP04/30/2001SCM30905011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020710Orig1s011.pdf 12/9/2011
AP011/8/2001SCS       
AP02/6/2006SLR13602015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020710s015s016_ltr.pdf 2/8/2006
AP02/6/2006SLR13603016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020710s015s016_ltr.pdf 2/8/2006
AP08/2/2007SLR17489017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020031s053,020710s017lbl.pdf 8/3/2007
AP08/2/2007SLR17598017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012342s059, 020031s053, 020710s017, 020936s029ltr.pdf 8/7/2007
AP08/22/2006SLR14923018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf 9/20/2006
AP08/22/2006SLR14924019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf 9/20/2006
AP07/8/2011SLR29478022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf 7/12/2011
AP07/8/2011SLR29497022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf 7/12/2011
AP08/7/2009SLR23742023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s05920710s023lbl.pdf 11/5/2009
AP08/7/2009SLR23983023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s059,020710s023,020936s035ltr.pdf 11/19/2009
AP010/31/2008SLR21123024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020031s060, 020936s037, 020710s024ltr.pdf 11/3/2008
AP010/31/2008SLR21150024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020031s060,020936s037,020710s024lbl.pdf 11/7/2008
AP01/30/2009SLR21731025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s061,020936s038,020710s025ltr.pdf 2/3/2009
AP01/30/2009SLR21756025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s061,020710s025lbl.pdf 2/4/2009
AP03/21/2011SLR28326026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf 3/24/2011
AP03/21/2011SLR28367026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf 3/28/2011
AP010/27/2010SLR26817027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020031s063,020710s027lbl.pdf 10/28/2010
AP010/27/2010SLR26854027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020031s063,020710s027,020936s041ltr.pdf 11/2/2010
AP03/21/2011SLR28327029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf 3/24/2011
AP03/21/2011SLR28368029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf 3/28/2011
AP07/8/2011SLR29479030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf 7/12/2011
AP07/8/2011SLR29498030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf 7/12/2011
AP012/18/2012SLR34716031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031Orig1s067,020710Orig1s031,020936Orig1s045ltr.pdf 12/21/2012
AP012/18/2012SLR34804031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s067,020710s031.pdf 12/31/2012
AP04/10/2012SLR32411032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031s068,020710s032,020936s046ltr.pdf 4/12/2012
AP04/10/2012SLR32446032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s068,20710s032lbl.pdf 4/17/2012
AP03/21/2011SLR28328033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf 3/24/2011
AP03/21/2011SLR28369033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf 3/28/2011
AP07/18/2014SLR39938035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020031Orig1s071,020710Orig1s035,020936Orig1s049ltr.pdf 7/23/2014
AP07/18/2014SLR40057035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020031s071,020710s035lbl.pdf 7/29/2014




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