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FDA Drug Application 125019 by SPECTRUM PHARMS

Application Number125019
Application Type Biologic License Application
Sponsor ApplicantSPECTRUM PHARMS
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
AP02/19/2002N81800000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ibriide021902L.htm 3/30/2004
AP02/19/2002N81810000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ibriide021902LB.pdf 3/30/2004
AP02/19/2002N132290000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125019_0000_ZevalinTOC.cfm 12/8/2005
AP010/2/2004S110220058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125019_0058ltr.pdf 1/26/2005
AP010/2/2004S110450058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0058lbl.pdf 1/26/2005
AP010/29/2004S110230070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125019_0070ltr.pdf 1/26/2005
AP010/29/2004S110420070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0070lbl.pdf 1/26/2005
AP07/27/2005S125620088   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125019_0088ltr.pdf 8/8/2005
AP07/27/2005S125740088   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0088lbl.pdf 8/8/2005
AP09/13/2005S127960092   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125019_0092ltr.pdf 9/15/2005
AP09/13/2005S127970092   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0092lbl.pdf 9/15/2005
AP011/2/2007S183560132   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125019s132ltr.pdf 11/8/2007
AP011/2/2007S184150132   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125019s132lbl.pdf 11/13/2007
AP03/25/2008S195470135   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125019s135lbl.pdf 3/27/2008
AP03/25/2008S195510135   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125019s0135ltr.pdf 3/28/2008
AP09/3/2009S232830156   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125019s0156ltr.pdf 9/10/2009
AP09/3/2009S234100156   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125019s0156.pdf 9/18/2009
AP011/18/2011S308150194   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125019s0194lbl.pdf 11/30/2011
AP011/18/2011S308370194   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125019s0194ltr.pdf 12/2/2011
AP08/30/2013SLR36951210   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125019Orig1s210,s213ltr.pdf 9/5/2013
AP08/30/2013SLR37025210   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf 9/9/2013
AP08/30/2013SLR37026213   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf 9/9/2013
AP08/30/2013SLR36952213   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125019Orig1s210,s213ltr.pdf 9/5/2013




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