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FDA Drug Application 205437 by CELGENE CORP

Application Number205437
Application Type New Drug Application
Sponsor ApplicantCELGENE CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/21/2014N38879000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205437Orig1s000ltr.pdf 3/25/2014
AP03/21/2014N38883000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205437s000lbl.pdf 3/25/2014
AP03/21/2014N39089000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205437Orig1s000TOC.cfm 4/17/2014
AP07/22/2014SCM       
AP07/28/2014SCM       
AP09/19/2014SCM       
AP04/27/2015SCM       
AP012/21/2015SLR44841005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205437Orig1s005ltr.pdf 12/22/2015
AP012/21/2015SLR44879005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205437s005lbl.pdf 12/28/2015




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