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FDA Drug Application 021046 by FOREST LABS

Application Number021046
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
AP012/22/1999N1035000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21046ltr.pdf 12/22/1999
AP012/22/1999N2352000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-046_Celexa.pdf 12/22/1999
AP012/22/1999N23913000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088568.pdf 11/16/2009
AP012/22/1999N45636000   http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm053339.htm 4/11/2016
AP012/1/2000SCS       
AP011/19/2002SLR2354003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20822slr019,21046slr003ltr.pdf 11/19/2002
AP04/8/2004SLR8361005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21046slr005,20822slr023ltr.pdf 4/20/2004
AP05/20/2004SLR8650007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20822slr027,21046slr007,21323slr015,21365slr008ltr.pdf 5/26/2004
AP02/18/2005SLR11144009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20822s029,21046s009,21323s020,21365s012ltr.pdf 2/23/2005
AP08/2/2007SLR17498013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021046s013lbl.pdf 8/3/2007
AP08/2/2007SLR17592013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020822s034, 021046s013, 021323s025, 021365s016ltr.pdf 8/7/2007
AP09/17/2008SLR20849014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020822s035,021046s014,ltr.pdf 9/19/2008
AP09/17/2008SLR20860014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020822s35,021046s14lbl.pdf 9/19/2008
AP01/30/2009SLR21724015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020822s037,021046s015,021323s032,021365s023ltr.pdf 2/3/2009
AP01/30/2009SLR21764015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020822s037,021046s015lbl.pdf 2/4/2009
AP08/12/2011SLR29799016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf 8/16/2011
AP08/12/2011SLR29813016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046s016,s017ltr.pdf 8/17/2011
AP08/12/2011SLR30238016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Orig1s016s017Rev.pdf 10/11/2011
AP08/12/2011SLR30239017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Orig1s016s017Rev.pdf 10/11/2011
AP08/12/2011SLR29814017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046s016,s017ltr.pdf 8/17/2011
AP08/12/2011SLR29800017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf 8/16/2011
AP03/27/2012SLR32272019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s042,021046s019lbl.pdf 3/29/2012
AP03/27/2012SLR32285019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822s042,021046s019ltr.pdf 3/29/2012
AP03/27/2012SLR37056019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021046Orig1s019.pdf 9/11/2013
AP012/3/2012SLR34532020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021046s020lbl.pdf 12/3/2012
AP012/3/2012SLR34553020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822Org1s043,021046Orig1s020,021323Orig1s040,021365Orig1s030ltr.pdf 12/5/2012




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