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FDA Drug Application 020823 by NOVARTIS

Application Number020823
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
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
AP04/21/2000N320000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20823lbl.pdf 4/21/2000
AP04/21/2000N1832000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20823ltr.pdf 4/21/2000
AP04/21/2000N1833000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20823_Exelon.cfm 4/21/2000
AP07/11/2000SCM       
AP01/31/2001SCM       
AP01/5/2001SLR5620003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20823S3LBL.PDF 1/5/2001
AP01/5/2001SLR16795003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020823_S003_EXELON_AP.pdf 6/18/2007
AP01/28/2002SCM       
AP01/25/2002SCM       
AP010/16/2002SCM       
AP010/24/2002SCP       
AP010/1/2013SLR37323009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf 10/4/2013
AP010/1/2013SLR37394009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf 10/8/2013
AP05/5/2004SLR8545012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823slr012,21025slr006ltr.pdf 5/7/2004
AP09/21/2004SLR10273014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823s014,21025s007ltr.pdf 9/24/2004
AP06/27/2006SE114382016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020823s016,021025s008lbl.pdf 6/28/2006
AP06/27/2006SE114408016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020823s016, 021025s008ltr.pdf 7/3/2006
AP06/27/2006SE127031016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020823_016_exelon.pdf 6/27/2006
AP010/1/2013SLR37324027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf 10/4/2013
AP010/1/2013SLR37395027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf 10/8/2013
AP010/1/2013SLR37325028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf 10/4/2013
AP010/1/2013SLR37393028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf 10/8/2013
AP010/1/2013SLR37326029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf 10/4/2013
AP010/1/2013SLR37396029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf 10/8/2013
AP03/21/2013SCM       
AP04/9/2014SCM       
AP02/3/2015SLR41792032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020823s032,021025s022lbl.pdf 2/5/2015
AP011/13/2015SCM       
AP01/22/2016SCM       




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