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FDA Drug Application 050778 by PFIZER INC

Application Number050778
Application Type New Drug Application
Sponsor ApplicantPFIZER INC
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
AP09/15/1999N8942000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-778_Ellence.cfm 6/3/2004
AP09/15/1999N1153000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50778ltr.pdf 9/15/1999
AP09/15/1999N1154000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50778lbl.pdf 9/15/1999
AP07/20/2000SCP       
AP04/3/2003SLR5393003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50778slr004ltr.pdf 4/18/2003
AP04/3/2003SLR5392004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50778slr004ltr.pdf 4/18/2003
AP03/2/2005SE811219008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50778s008ltr.pdf 3/10/2005
AP03/2/2005SE811234008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/50778s008lbl.pdf 3/10/2005
AP09/14/2011SLR30020015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf 9/16/2011
AP09/14/2011SLR30032015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018ltr.pdf 9/19/2011
AP09/14/2011SLR30033017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018ltr.pdf 9/19/2011
AP09/14/2011SLR30021017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf 9/16/2011
AP09/14/2011SLR30022018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf 9/16/2011
AP09/14/2011SLR30034018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018ltr.pdf 9/19/2011
AP02/19/2013SLR35203019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050778Orig1s019ltr.pdf 2/21/2013
AP02/19/2013SLR35221019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050778s019lbl.pdf 2/21/2013
AP012/15/2014SLR41258021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050778Orig1s021ltr.pdf 12/16/2014
AP012/15/2014SLR41265021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050778s021lbl.pdf 12/16/2014




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