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FDA Drug Application 007409 by FOREST LABS INC

Application Number007409
Application Type New Drug Application
Sponsor ApplicantFOREST LABS INC
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
AP05/11/1950N       
AP08/4/1989SPD       
AP010/15/1984SLR       
AP010/15/1984SCS       
AP05/13/1985SLR       
AP06/12/1985SCS       
AP02/6/1987SLR       
AP03/15/1990SCP       
AP06/15/1989SCM       
AP01/4/1993SCM       
AP09/25/1990SLR       
AP06/24/1992SCF       
AP010/29/1991SCP       
AP09/9/1996SLR       
AP08/17/1999SLR       
AP02/2/2007SLR15798040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/007409s040, 007961s026, 008370s031LTR.pdf 2/12/2007
AP02/2/2007SLR15851040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf 2/21/2007
AP08/1/2011SLR29644041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007409s041lbl.pdf 8/1/2011
AP08/1/2011SLR29648041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf 8/2/2011
AP01/11/2013SLR34884042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/007409Orig1s042,008370Orig1s033ltr.pdf 1/15/2013
AP01/11/2013SLR34891042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.pdf 1/15/2013




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