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FDA Drug Application 021252 by FOREST LABS LLC

Application Number021252
Application Type New Drug Application
Sponsor ApplicantFOREST LABS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/5/2001N1537000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21252ltr.pdf 1/5/2001
AP01/5/2001N2292000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-252_Canasa.cfm 1/5/2001
AP01/5/2001N5000000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21252lbl.pdf 4/8/2003
AP010/14/2003SLR6815002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21252slr002ltr.pdf 10/17/2003
AP011/5/2004SE210550005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21252s005ltr.pdf 11/8/2004
AP011/5/2004SE210563005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21252s005lbl.pdf 11/8/2004
AP09/23/2004SLR10305006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21252s006ltr.pdf 9/29/2004
AP06/8/2006SLR14292007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021252s007LTR.pdf 6/12/2006
AP05/23/2008SCP19882009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021252s009ltr.pdf 5/28/2008
AP02/6/2013SLR35097013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021252Orig1s013ltr.pdf 2/7/2013
AP02/6/2013SLR35114013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021252s013lbl.pdf 2/8/2013
AP09/2/2016SE846974014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021252Orig1s014ltr.pdf 9/6/2016
AP09/2/2016SE846981014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021252s014lbl.pdf 9/7/2016
AP05/3/2013SCM       
AP012/24/2013SCM       
AP01/2/2014SCM       
AP012/17/2013SLR38105020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021252s020lbl.pdf 12/19/2013
AP012/17/2013SLR38112020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021252Orig1s020ltr.pdf 12/20/2013
AP07/30/2014SCM       




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