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FDA Drug Application 021431 by FOREST LABS

Application Number021431
Application Type New Drug Application
Sponsor ApplicantFOREST LABS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/29/2004N9916000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21431ltr.pdf 7/30/2004
AP07/29/2004N9919000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21431lbl.pdf 7/30/2004
AP07/29/2004N10433000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-431_Campral.cfm 10/18/2004
AP012/13/2010SLR27280013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021431s013lbl.pdf 12/13/2010
AP012/13/2010SLR27285013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021431s013ltr.pdf 12/15/2010
AP01/30/2012SLR31607015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021431s015lbl.pdf 1/30/2012
AP01/30/2012SLR31620015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021431s015ltr.pdf 2/1/2012
AP09/20/2013SCM       
AP08/10/2015SCM       




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