Back to FDA Applications sponsored by FOREST LABS

FDA Drug Application 021323 by FOREST LABS

Application Number021323
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
AP08/14/2002N2880000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21323ltr.pdf 8/14/2002
AP08/14/2002N2881000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21323lbl.pdf 8/14/2002
AP08/14/2002N12369000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053342.htm 7/29/2005
AP08/14/2002N8329000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-323_Lexapro.cfm 4/12/2004
AP08/14/2002N24006000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088620.pdf 11/19/2009
AP08/29/2002SE89168001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-440.pdf_Lexapro_Prntlbl.pdf 6/8/2004
AP08/29/2002SE82879001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21323se8-001and21440ltr.pdf 8/29/2002
AP08/29/2002SE88328001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-440_21323s1_Lexapro.cfm 4/12/2004
AP012/13/2002SCM       
AP012/18/2003SE17312003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf 12/22/2003
AP012/18/2003SE17297003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21323se1-003,se8-007,21365se8-001,se1-004ltr.pdf 12/22/2003
AP012/18/2003SE117014003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S003&021365_S004_LEXAPRO_TABS.pdf 7/6/2007
AP012/18/2003SE817015007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S007&021365_S001_LEXAPRO_TABS.pdf 7/6/2007
AP012/18/2003SE87298007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21323se1-003,se8-007,21365se8-001,se1-004ltr.pdf 12/22/2003
AP012/18/2003SE87313007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf 12/22/2003
AP04/8/2004S       
AP01/11/2005SLR10953014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21323s014,21365s007ltr.pdf 1/13/2005
AP05/20/2004SLR8651015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20822slr027,21046slr007,21323slr015,21365slr008ltr.pdf 5/26/2004
AP02/18/2005SLR11145020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20822s029,21046s009,21323s020,21365s012ltr.pdf 2/23/2005
AP08/2/2007SLR17497025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021323s025lbl.pdf 8/3/2007
AP08/2/2007SLR17591025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020822s034, 021046s013, 021323s025, 021365s016ltr.pdf 8/7/2007
AP09/17/2008SLR20850028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021323s028,s029,021365s018,s019ltr.pdf 9/19/2008
AP09/17/2008SLR20861028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021323s28s29,021365s18s19lbl.pdf 9/19/2008
AP010/11/2008SLR21039029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021323s029, 021365s019ltr.pdf 10/21/2008
AP03/19/2009SE522087030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021323s030,s031,021365s021,s022ltr.pdf 3/24/2009
AP03/19/2009SE522113030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s030s031,021365s021s022lbl.pdf 3/25/2009
AP03/19/2009SE531543030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021323Orig1S030_s031.pdf 1/27/2012
AP03/19/2009SE522114031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s030s031,021365s021s022lbl.pdf 3/25/2009
AP03/19/2009SE522088031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021323s030,s031,021365s021,s022ltr.pdf 3/24/2009
AP03/19/2009SE531542031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021323Orig1S030_s031.pdf 1/27/2012
AP01/30/2009SLR21725032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020822s037,021046s015,021323s032,021365s023ltr.pdf 2/3/2009
AP01/30/2009SLR21775032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s032,021365s023lbl.pdf 2/4/2009
AP05/12/2011SLR28812033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021323s033,021365s024ltr.pdf 5/16/2011
AP05/12/2011SLR28832033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s033,021365s024MedG.pdf 5/16/2011
AP05/12/2011SLR28834033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s033,021365s024lbl.pdf 5/16/2011
AP03/11/2011SLR28220035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s035,021365s025lbl.pdf 3/11/2011
AP03/11/2011SLR28256035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021323s035,021365s025ltr.pdf 3/16/2011
AP03/7/2013SCM       
AP012/3/2012SLR34531040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021323s040lbl.pdf 12/3/2012
AP012/3/2012SLR34554040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822Org1s043,021046Orig1s020,021323Orig1s040,021365Orig1s030ltr.pdf 12/5/2012
AP05/29/2013SCM       
AP010/31/2014SLR40921044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021323Orig1s044,021365Orig1s032ltr.pdf 11/3/2014
AP010/31/2014SLR40944044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021323s044,021365s032lbl.pdf 11/4/2014
AP07/8/2014SLR39832045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020822Orig1s046,021323Orig1s045,021365Orig1s033ltr.pdf 7/10/2014
AP07/8/2014SLR39908045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021323Orig1s045,021365Orig1s033lbl.pdf 7/21/2014
AP01/28/2016SCM       




Back to FDA Applications sponsored by FOREST LABS