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FDA Drug Application 203202 by LUNDBECK NA LTD

Application Number203202
Application Type New Drug Application
Sponsor ApplicantLUNDBECK NA LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/18/2014N38535000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203202Orig1s000ltr.pdf 2/19/2014
AP02/18/2014N38536000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203202lbl.pdf 2/19/2014
AP02/18/2014N38862000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203202Orig1s000TOC.cfm 3/20/2014
AP011/3/2014SCM       
AP09/30/2014SCM       
AP011/3/2014SCM       
AP08/19/2015SCM       
AP08/24/2015SCM       
AP010/3/2016SLR47281006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203202Orig1s006ltr.pdf 10/5/2016
AP010/3/2016SLR47286006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203202s006lbl.pdf 10/6/2016




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