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FDA Drug Application 021688 by AMGEN

Application Number021688
Application Type New Drug Application
Sponsor ApplicantAMGEN
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
AP03/8/2004N7845000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21688ltr.pdf 3/10/2004
AP03/8/2004N8222000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21688_sensipar_lbl.pdf 4/5/2004
AP03/8/2004N8567000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-688_Sensipar.cfm 5/10/2004
AP010/4/2007SLR18190006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021688s006ltr.pdf 10/10/2007
AP010/4/2007SLR18224006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021688s006lbl.pdf 10/10/2007
AP02/28/2008SLR19350008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021688s008ltr.pdf 3/4/2008
AP02/28/2008SLR19372008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s008lbl.pdf 3/5/2008
AP05/2/2008SLR19780009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021688s009ltr.pdf 5/7/2008
AP012/19/2008SLR21419011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021688s011ltr.pdf 12/29/2008
AP012/19/2008SLR21505011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s011lbl.pdf 1/6/2009
AP011/12/2009SLR23898013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021688s013lbl.pdf 11/16/2009
AP011/12/2009SLR24569013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021688s013ltr.pdf 1/21/2010
AP02/25/2011SE128006015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021688s015ltr.pdf 3/2/2011
AP02/25/2011SE128053015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s015lbl.pdf 3/4/2011
AP08/1/2011SLR29657017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021688s017ltr.pdf 8/3/2011
AP08/1/2011SLR29771017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s017lbl.pdf 8/12/2011
AP011/21/2014SLR41080020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021688Orig1s020,s021,s022ltr.pdf 11/24/2014
AP011/21/2014SLR41084020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf 11/25/2014
AP011/21/2014SE841081021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021688Orig1s020,s021,s022ltr.pdf 11/24/2014
AP011/21/2014SE841085021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf 11/25/2014
AP011/21/2014SLR41082022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021688Orig1s020,s021,s022ltr.pdf 11/24/2014
AP011/21/2014SLR41086022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf 11/25/2014




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