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FDA Drug Application 021365 by FOREST LABS

Application Number021365
Application Type New Drug Application
Sponsor ApplicantFOREST LABS
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
AP011/27/2002N2877000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21365ltr.pdf 11/27/2002
AP011/27/2002N2878000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21365_Lexapro_lbl.pdf 11/27/2002
AP011/27/2002N9596000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-365_Lexapro.cfm 6/29/2004
AP011/27/2002N12370000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053342.htm 7/29/2005
AP011/27/2002N24007000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088620.pdf 11/19/2009
AP012/18/2003SE87299001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21323se1-003,se8-007,21365se8-001,se1-004ltr.pdf 12/22/2003
AP012/18/2003SE87314001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf 12/22/2003
AP012/18/2003SE817016001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S007&021365_S001_LEXAPRO_TABS.pdf 7/6/2007
AP012/18/2003SE17300004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21323se1-003,se8-007,21365se8-001,se1-004ltr.pdf 12/22/2003
AP012/18/2003SE17315004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf 12/22/2003
AP012/18/2003SE117013004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S003&021365_S004_LEXAPRO_TABS.pdf 7/6/2007
AP04/8/2004S       
AP01/11/2005SLR10954007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21323s014,21365s007ltr.pdf 1/13/2005
AP05/20/2004SLR8652008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20822slr027,21046slr007,21323slr015,21365slr008ltr.pdf 5/26/2004
AP02/18/2005SLR11146012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20822s029,21046s009,21323s020,21365s012ltr.pdf 2/23/2005
AP08/2/2007SLR       
AP09/17/2008SLR20852018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021323s028,s029,021365s018,s019ltr.pdf 9/19/2008
AP09/17/2008SLR20863018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021323s28s29,021365s18s19lbl.pdf 9/19/2008
AP010/11/2008SLR21040019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021323s029, 021365s019ltr.pdf 10/21/2008
AP03/19/2009SE522089021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021323s030,s031,021365s021,s022ltr.pdf 3/24/2009
AP03/19/2009SE522111021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s030s031,021365s021s022lbl.pdf 3/25/2009
AP03/19/2009SE522090022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021323s030,s031,021365s021,s022ltr.pdf 3/24/2009
AP03/19/2009SE522112022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s030s031,021365s021s022lbl.pdf 3/25/2009
AP01/30/2009SLR21726023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020822s037,021046s015,021323s032,021365s023ltr.pdf 2/3/2009
AP01/30/2009SLR21774023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s032,021365s023lbl.pdf 2/4/2009
AP05/12/2011SLR28813024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021323s033,021365s024ltr.pdf 5/16/2011
AP05/12/2011SLR28831024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s033,021365s024MedG.pdf 5/16/2011
AP05/12/2011SLR28833024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s033,021365s024lbl.pdf 5/16/2011
AP03/11/2011SLR28219025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s035,021365s025lbl.pdf 3/11/2011
AP03/11/2011SLR28257025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021323s035,021365s025ltr.pdf 3/16/2011
AP012/3/2012SLR34530030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021365s030lbl.pdf 12/3/2012
AP012/3/2012SLR34555030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822Org1s043,021046Orig1s020,021323Orig1s040,021365Orig1s030ltr.pdf 12/5/2012
AP010/31/2014SLR40922032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021323Orig1s044,021365Orig1s032ltr.pdf 11/3/2014
AP010/31/2014SLR40943032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021323s044,021365s032lbl.pdf 11/4/2014
AP07/8/2014SLR39833033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020822Orig1s046,021323Orig1s045,021365Orig1s033ltr.pdf 7/10/2014
AP07/8/2014SLR39909033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021323Orig1s045,021365Orig1s033lbl.pdf 7/21/2014




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