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FDA Drug Application 021627 by FOREST LABS LLC

Application Number021627
Application Type New Drug Application
Sponsor ApplicantFOREST LABS LLC
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
AP04/18/2005N11437000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021627ltr.pdf 4/19/2005
AP04/18/2005N11438000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021627lbl.pdf 4/19/2005
AP04/18/2005N15134000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021627s000_NamendaTOC.cfm 10/18/2006
AP010/4/2006SLR15096001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s008,021627s001LTR.pdf 10/13/2006
AP04/19/2006SLR13971002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s007, 021627s002LTR.pdf 4/21/2006
AP010/24/2013SLR37570008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf 10/25/2013
AP010/24/2013SLR37577008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf 10/25/2013
AP07/10/2014SCM       
AP08/11/2014SLR40202012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021627Orig1s012ltr.pdf 8/12/2014
AP08/11/2014SLR40213012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021627s012lbl.pdf 8/12/2014




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