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FDA Drug Application 019183 by FOREST LABS INC

Application Number019183
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
AP012/16/1993N27856000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019183_biopharm.pdf 2/15/2011
AP04/11/1994SCS       
AP07/13/1994SLR       
AP08/21/1995SCP       
AP08/14/1997SCP       
AP07/16/1997SCS       
AP02/8/2000SCS       
AP02/10/2006SCP13651009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019183s009ltr.pdf 2/22/2006
AP04/26/2007SLR16348011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019183s011lbl.pdf 5/1/2007
AP04/26/2007SLR16381011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019183s011ltr.pdf 5/1/2007
AP012/21/2010SLR27379014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019183s014lbl.pdf 12/26/2010
AP012/21/2010SLR27398014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019183s014ltr.pdf 12/28/2010
AP03/4/2013SLR35336016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018333Orig1s034,019183Orig1s016ltr.pdf 3/5/2013
AP03/4/2013SLR35394016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf 3/8/2013
AP06/6/2016SCM       




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