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FDA Drug Application 103949 by SCHERING

Application Number103949
Application Type Biologic License Application
Sponsor ApplicantSCHERING
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
AP01/19/2001N80640000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/pegsche011901L.htm 3/25/2004
AP01/19/2001N80650000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/pegsche011901LB.PDF 3/25/2004
AP01/19/2001N80660000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM133677.pdf 3/25/2004
AP01/19/2001N80670000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080727.htm 3/25/2004
AP08/7/2001S80685002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/pegsche080701L.htm 3/25/2004
AP08/7/2001S80695002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/pegsche080701LB.htm 3/25/2004
AP08/7/2001S132285002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/103949s5002_PEGIntronTOC.cfm 12/8/2005
AP011/3/2005S131025077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103949s5077ltr.pdf 11/3/2005
AP011/3/2005S131215077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103949s5077lbl.pdf 11/18/2005
AP010/15/2004S110475088   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103949_5088lbl.pdf 1/26/2005
AP010/15/2004S110485088   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103949_5088ltr.pdf 1/26/2005
AP07/22/2005S125615105   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103949_5105ltr.pdf 8/8/2005
AP07/22/2005S125675105   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103949_5105lbl.pdf 8/8/2005
AP012/22/2006S156465124   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103949s5124LTR.pdf 1/16/2007
AP012/22/2006S156475124   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103949s5124LBL.pdf 1/16/2007
AP03/10/2009S220605125   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103949s5125lbl.pdf 3/19/2009
AP03/10/2009S220775125   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103949s5125ltr.pdf 3/23/2009
AP03/29/2011S284065153   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5153lbl.pdf 3/31/2011
AP03/29/2011S284135153   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5153ltr.pdf 3/31/2011
AP012/11/2008S214025171   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103949s5171, s5174ltr.pdf 12/24/2008
AP012/11/2008S216575171   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103949s5171, s5174lbl.pdf 1/16/2009
AP05/8/2009S227085172   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103949s5172lbl.pdf 6/7/2009
AP05/8/2009S227095172   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103949s5172ltr.pdf 6/8/2009
AP012/11/2008S216585174   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103949s5171, s5174lbl.pdf 1/16/2009
AP012/11/2008S214035174   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103949s5171, s5174ltr.pdf 12/24/2008
AP05/20/2009S227245175   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103949s5175ltr.pdf 6/10/2009
AP02/1/2011S278575201   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5201ltr.pdf 2/15/2011
AP06/6/2011S308915204   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5204lbl.pdf 12/7/2011
AP06/6/2011S309235204   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5204ltr.pdf 12/13/2011
AP012/22/2011S312495217   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5217s5222lbl.pdf 12/23/2011
AP012/22/2011S312805217   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5217,s5222ltr.pdf 12/28/2011
AP012/22/2011S312815222   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5217,s5222ltr.pdf 12/28/2011
AP012/22/2011S312505222   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5217s5222lbl.pdf 12/23/2011
AP06/4/2012SLR328445231   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103949s5231ltr.pdf 6/7/2012
AP07/2/2012S330805232   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103949s5232lbl.pdf 7/6/2012
AP07/2/2012S330825232   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103949s5232ltr.pdf 7/9/2012
AP012/26/2012SLR347875252   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103949Orig1s5252ltr.pdf 12/28/2012
AP012/26/2012SLR347925252   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103949s5252lbl.pdf 12/28/2012
AP012/18/2013SE8381025259   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103949s5259lbl.pdf 12/19/2013
AP012/18/2013SE8381145259   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103949Orig1s5259ltr.pdf 12/20/2013
AP05/15/2013SLR360875263   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103949Orig1s5263ltr.pdf 5/16/2013
AP05/15/2013SLR361125263   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103949s5263lbl.pdf 5/21/2013
AP011/15/2013SLR379005273   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103949s5273lbl.pdf 11/22/2013
AP011/15/2013SLR379015273   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103949Orig1s5273ltr.pdf 11/25/2013
AP08/14/2014SLR402455285   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5285ltr.pdf 8/15/2014
AP08/14/2014SLR402495285   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5285lbl.pdf 8/15/2014
AP08/30/2014SLR403905287   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5287lbl.pdf 9/3/2014
AP08/30/2014SLR404505287   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5287ltr.pdf 9/8/2014
AP08/11/2014SLR402035288   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5288ltr.pdf 8/12/2014
AP08/11/2014SLR402125288   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5288lbl.pdf 8/12/2014
AP011/17/2014SLR410235293   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5293ltr.pdf 11/19/2014
AP011/17/2014SLR410535293   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5293lbl.pdf 11/20/2014
AP07/31/2014SLR400905295   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5295ltr.pdf 8/1/2014
AP07/31/2014SLR401095295   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5295lbl.pdf 8/1/2014
AP010/9/2014N407555296   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5296ltr.pdf 10/10/2014
AP05/21/2015SLR428895297   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103949Orig1s5297ltr.pdf 5/22/2015
AP05/21/2015SLR429145297   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103949s5297lbl.pdf 5/27/2015
AP05/13/2015SLR428255298   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103949s5298lbl.pdf 5/14/2015
AP05/13/2015SLR428305298   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103949Orig1s5298ltr.pdf 5/19/2015
AP09/16/2015SLR439115299   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103949Orig1s5299ltr.pdf 9/17/2015
AP09/16/2015SLR439645299   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103949s5299lbl.pdf 9/23/2015




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