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FDA Drug Application 018333 by FOREST LABS INC

Application Number018333
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/30/1981N       
AP03/9/1982SCP       
AP08/16/1982SLR       
AP06/9/1983SCP       
AP06/1/1983SCP       
AP04/22/1983SLR       
AP09/24/1984SLR       
AP05/14/1985SLR       
AP05/11/1990SE1       
AP08/5/1987SCS       
AP09/24/1985SCP       
AP08/5/1987SCS       
AP07/2/1986SLR       
AP012/19/1988SLR       
AP05/5/1988SCP       
AP012/16/1988SCP       
AP05/11/1990SLR       
AP010/5/1990SCS       
AP02/12/1991SLR       
AP012/28/1992SLR       
AP07/14/1994SLR       
AP08/15/1995SCP       
AP011/29/1995SCP       
AP04/26/2007SLR16349032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018333s032lbl.pdf 5/1/2007
AP04/26/2007SLR16382032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018333s032ltr.pdf 5/1/2007
AP03/4/2013SLR35337034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018333Orig1s034,019183Orig1s016ltr.pdf 3/5/2013
AP03/4/2013SLR35395034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf 3/8/2013




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