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FDA Drug Application 008370 by FOREST LABS INC

Application Number008370
Application Type New Drug Application
Sponsor ApplicantFOREST LABS INC
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
AP08/13/1952N       
AP08/4/1989SPD       
AP010/15/1984SLR       
AP010/15/1984SCS       
AP05/13/1985SLR       
AP06/12/1985SCS       
AP02/6/1987SLR       
AP02/18/1988SCM       
AP01/4/1993SCM       
AP09/25/1990SLR       
AP03/18/1991SCS       
AP012/23/1991SLR       
AP09/6/1996SLR       
AP08/17/1999SLR       
AP06/23/2000SCP       
AP08/12/2002SLR4425030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08-370slr030ltr.pdf 8/12/2002
AP02/2/2007SLR15796031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/007409s040, 007961s026, 008370s031LTR.pdf 2/12/2007
AP02/2/2007SLR15849031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf 2/21/2007
AP08/1/2011SLR29642032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008370s032lbl.pdf 8/1/2011
AP08/1/2011SLR29650032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf 8/2/2011
AP01/11/2013SLR34883033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/007409Orig1s042,008370Orig1s033ltr.pdf 1/15/2013
AP01/11/2013SLR34890033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.pdf 1/15/2013
AP010/12/2016SCM       




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