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FDA Drug Application 103471 by BAYER HEALTHCARE PHARMS

Application Number103471
Application Type Biologic License Application
Sponsor ApplicantBAYER HEALTHCARE 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
AP07/23/1993N167300000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/103471s0000TOC.cfm 6/11/2007
AP03/14/2003S79031039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbchi031403L.htm 3/11/2004
AP03/14/2003S79041039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbchi031403LB.pdf 3/11/2004
AP03/14/2003S79051039   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088565.pdf 3/11/2004
AP03/14/2003S79061039   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080486.htm 3/11/2004
AP010/10/2003S68495032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/103471s5032medguide.pdf 10/31/2003
AP010/10/2003S68505032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103471-5032ltr.pdf 10/31/2003
AP010/10/2003S196805032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/103471s5032lbl.pdf 4/21/2008
AP06/8/2005S       
AP012/11/2012SLR346105063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf 12/13/2012
AP012/11/2012SLR346355063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf 12/13/2012
AP012/11/2012SLR346435063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138mg.pdf 12/13/2012
AP07/28/2005S       
AP07/28/2005S       
AP012/11/2012SLR346115067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf 12/13/2012
AP012/11/2012SLR346365067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf 12/13/2012
AP012/11/2012SLR346445067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138mg.pdf 12/13/2012
AP012/7/2005S       
AP012/29/2005S       
AP012/29/2005S       
AP012/11/2012SLR346125079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf 12/13/2012
AP012/11/2012SLR346375079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf 12/13/2012
AP012/11/2012SLR346455079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138mg.pdf 12/13/2012
AP04/4/2006S       
AP04/26/2007S       
AP011/9/2006S       
AP012/11/2012SLR346135088   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf 12/13/2012
AP012/11/2012SLR346385088   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf 12/13/2012
AP012/11/2012SLR346465088   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138mg.pdf 12/13/2012
AP07/18/2007S       
AP012/11/2012SLR346145120   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf 12/13/2012
AP012/11/2012SLR346395120   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf 12/13/2012
AP012/11/2012SLR346475120   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138mg.pdf 12/13/2012
AP09/8/2008S       
AP012/11/2012SLR346155124   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf 12/13/2012
AP012/11/2012SLR346405124   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf 12/13/2012
AP012/11/2012SLR346485124   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138mg.pdf 12/13/2012
AP06/28/2013SCM364065125   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103471Orig1s5125ltr.pdf 7/2/2013
AP06/28/2013SCM365325125   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103471s5125lbl.pdf 7/11/2013
AP03/26/2009S       
AP012/11/2012SLR346165136   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf 12/13/2012
AP012/11/2012SLR346415136   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf 12/13/2012
AP012/11/2012SLR346495136   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138mg.pdf 12/13/2012
AP012/11/2012SLR346175138   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf 12/13/2012
AP012/11/2012SLR346425138   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf 12/13/2012
AP012/11/2012SLR346505138   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138mg.pdf 12/13/2012
AP04/19/2016SLR       
AP01/28/2014SLR383995185   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103471Orig1s5185ltr.pdf 1/29/2014
AP01/28/2014SLR384155185   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103471s5185lbl.pdf 1/31/2014
AP09/25/2015SE8440085186   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103471Orig1s5186ltr.pdf 9/28/2015
AP09/25/2015SE8441545186   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103471s5186lbl.pdf 10/7/2015
AP04/19/2016SLR457315187   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103471Orig1s5187ltr.pdf 4/22/2016
AP04/19/2016SLR457795187   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103471s5157lbl.pdf 4/27/2016
AP012/22/2015S448755188   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103471Orig1s5188ltr.pdf 12/23/2015
AP012/22/2015S448885188   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103471s5188lbl.pdf 12/28/2015




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