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FDA Drug Application 021214 by SUCAMPO PHARMA LLC

Application Number021214
Application Type New Drug Application
Sponsor ApplicantSUCAMPO PHARMA LLC
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
AP08/3/2000N1456000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21214ltr.pdf 8/3/2000
AP08/3/2000N1457000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21214lbl.pdf 8/3/2000
AP08/3/2000N9385000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21214_Rescula.cfm 6/16/2004
AP012/5/2001SCS       
AP012/7/2012SCM44512006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021214Orig1s006.pdf 11/18/2015
AP012/7/2012SCM34572006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf 12/10/2012
AP012/7/2012SLR34573007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf 12/10/2012
AP012/7/2012SLR44498007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021214Orig1s007.pdf 11/17/2015
AP07/10/2014SCM       




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