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FDA Drug Application 021902 by MEDIGENE AG

Application Number021902
Application Type New Drug Application
Sponsor ApplicantMEDIGENE AG
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/31/2006N15298000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021902lbl.pdf 11/6/2006
AP010/31/2006N15309000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021902s000ltr.pdf 11/6/2006
AP010/31/2006N15616000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021902s000TOC.cfm 1/8/2007
AP06/1/2007SLR16684001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s001lbl.pdf 6/4/2007
AP06/1/2007SLR16716001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s001ltr.pdf 6/7/2007
AP16/21/2007SLR16684001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s001lbl.pdf 6/4/2007
AP16/21/2007SLR16716001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s001ltr.pdf 6/7/2007
AP012/19/2007SE818677002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s002lbl.pdf 12/27/2007
AP012/19/2007SE818810002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s002ltr.pdf 1/9/2008
AP09/18/2008SLR20866017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021902s017lbl.pdf 9/19/2008
AP09/18/2008SLR20876017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021902s017ltr.pdf 9/23/2008
AP011/19/2012SLR34443025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021902Orig1s025ltr.pdf 11/21/2012
AP011/19/2012SLR34469025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021902s025lbl.pdf 11/26/2012
AP03/1/2013SCM35322026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021902Orig1s026ltr.pdf 3/4/2013
AP05/31/2013SCM       
AP05/9/2013SCM       
AP07/6/2015SCM       
AP07/8/2016SCM       




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