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FDA Drug Application 021487 by FOREST LABS LLC

Application Number021487
Application Type New Drug Application
Sponsor ApplicantFOREST LABS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/16/2003N6829000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021487lbl.pdf 10/20/2003
AP010/16/2003N6835000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21487ltr.pdf 10/22/2003
AP010/16/2003N7458000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-487_Namenda.cfm 12/31/2003
AP09/22/2004SCS10306002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21487s002ltr.pdf 9/29/2004
AP05/2/2005SLR11570004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021487s004ltr.pdf 5/3/2005
AP05/17/2005SCF11673006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021487s006ltr.pdf 5/20/2005
AP04/19/2006SLR13972007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s007, 021627s002LTR.pdf 4/21/2006
AP010/4/2006SLR15095008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s008,021627s001LTR.pdf 10/13/2006
AP010/24/2013SLR37567010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487s010ltr.pdf021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf 10/25/2013
AP010/24/2013SLR37578010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf 10/25/2013
AP010/24/2013SLR37579012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf 10/25/2013
AP010/24/2013SLR37568012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf 10/25/2013
AP010/24/2013SLR37569014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf 10/25/2013
AP010/24/2013SLR37580014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf 10/25/2013
AP03/11/2013SCM       
AP011/14/2013SCM       
AP04/29/2015SCM       
AP03/7/2016SCM       
AP05/18/2016SCM       




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