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FDA Drug Application 021908 by SUCAMPO PHARMA LLC

Application Number021908
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/31/2006N13576000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021908s000lbl.pdf 2/2/2006
AP01/31/2006N13579000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021908s000ltr.pdf 2/2/2006
AP01/31/2006N13831000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021908s000_AmitizaTOC.cfm 3/24/2006
AP05/16/2007SLR16620004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021908s004ltr.pdf 5/29/2007
AP05/16/2007SLR16628004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021908s004lbl.pdf 5/29/2007
AP04/29/2008SE119754005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021908s005lbl.pdf 5/2/2008
AP04/29/2008SE119766005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021908se1-005ltr.pdf 5/5/2008
AP04/29/2008SE120253005   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021908se1-005_SUMR.pdf 7/17/2008
AP04/29/2008SE125406005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021908s005TOC.cfm 5/3/2010
AP02/24/2011SLR27991008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021908s008ltr.pdf 3/1/2011
AP02/24/2011SLR28046008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021908s008lbl.pdf 3/4/2011
AP02/24/2011SLR34356008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021908Orig1s008.pdf 11/9/2012
AP011/26/2012SLR34475010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021908s010lbl.pdf 11/26/2012
AP011/26/2012SLR34477010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021908Orig1s010ltr.pdf 11/28/2012
AP011/26/2012SLR36702010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021908Orig1s010.pdf 8/6/2013
AP04/19/2013SE135787011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021908s011lbl.pdf 4/23/2013
AP04/19/2013SE135833011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021908Orig1s011ltr.pdf 4/24/2013
AP04/19/2013SE143693011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021908Orig1s011.pdf 8/21/2015
AP08/19/2013SCM       
AP010/11/2016SLR47356013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021908Orig1s013ltr.pdf 10/14/2016




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