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FDA Drug Application 021025 by NOVARTIS

Application Number021025
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/21/2000N943000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20823ltr.pdf 4/21/2000
AP04/21/2000N944000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21025lbl.pdf 4/21/2000
AP04/21/2000N1834000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-025_Exelon.cfm 4/21/2000
AP07/11/2000SCM       
AP01/31/2001SCP       
AP01/5/2001SLR16796003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021025_S003_EXELON_AP.pdf 6/18/2007
AP01/28/2002SCM       
AP01/25/2002SCM       
AP05/5/2004SLR8546006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823slr012,21025slr006ltr.pdf 5/7/2004
AP09/21/2004SLR10272007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823s014,21025s007ltr.pdf 9/24/2004
AP06/27/2006SE114381008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020823s016,021025s008lbl.pdf 6/28/2006
AP06/27/2006SE114409008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020823s016, 021025s008ltr.pdf 7/3/2006
AP06/27/2006SE127032008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021025_s008_exelon_capsules.pdf 6/27/2006
AP010/1/2013SLR37327018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf 10/4/2013
AP010/1/2013SLR37397018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf 10/8/2013
AP010/1/2013SLR37398019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf 10/8/2013
AP010/1/2013SLR37328019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf 10/4/2013
AP010/1/2013SLR37329020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf 10/4/2013
AP010/1/2013SLR37399020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf 10/8/2013
AP02/3/2015SLR41786022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020823Orig1s032,021025Orig1s022ltr.pdf 2/5/2015
AP02/3/2015SLR41793022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020823s032,021025s022lbl.pdf 2/5/2015




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