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FDA Drug Application 103770 by MEDIMMUNE

Application Number103770
Application Type Biologic License Application
Sponsor ApplicantMEDIMMUNE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/19/1998N81520000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093366.htm 3/29/2004
AP06/19/1998N81540000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/palimed061998L.htm 3/29/2004
AP010/23/2002S81555022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/palimed102302L.pdf 3/29/2004
AP010/23/2002S81565022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/palimed102302LB.pdf 3/29/2004
AP09/15/2003SE8367405033   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2003/103770Orig1s5033.pdf 8/9/2013
AP012/14/2004S367385059   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2004/103770Orig1s5059.pdf 8/9/2013
AP012/14/2004S107975059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103770_s5059_lbl.pdf 12/22/2004
AP012/14/2004S111845059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103770_s5059_ltr.pdf 3/3/2005
AP02/28/2007S159475096   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103770_5096LTR.pdf 3/6/2007
AP02/28/2007S159965096   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103770_5096lbl.pdf 3/7/2007
AP08/1/2008SLR205095113   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103770s5113ltr.pdf 8/5/2008
AP08/1/2008SLR212535113   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103770s5113lbl.pdf 11/20/2008
AP03/23/2009S220865116   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103770s5116lbl.pdf 3/24/2009
AP03/23/2009S220975116   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103770s5116ltr.pdf 3/24/2009
AP04/4/2011SLR288415153   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103770s5153ltr.pdf 5/17/2011
AP04/4/2012SE8323615161   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103770s5161ltr.pdf 4/6/2012
AP04/4/2012SE8323645161   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103770s5161lbl.pdf 4/6/2012
AP03/21/2014SLR388755185   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103770Orig1s5185ltr.pdf 3/24/2014
AP03/21/2014SLR388905185   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103770s5185lbl.pdf 3/25/2014




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