Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022083
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EXELON RIVASTIGMINE 4.6MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes No
EXELON RIVASTIGMINE 9.5MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes Yes
EXELON RIVASTIGMINE 13.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/06/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022083_exelon_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/18/2018 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022083s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022083Orig1s026ltr.pdf
11/02/2016 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022083s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020823s035,021025s023,022083s023ltr.pdf
06/24/2015 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/03/2015 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022083s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022083Orig1s020ltr.pdf
06/27/2013 SUPPL-19 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022083s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022083Orig1s019ltr.pdf
03/13/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/31/2012 SUPPL-16 Efficacy-Manufacturing Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022083s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022083Orig1s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022083Orig1s016.pdf
08/27/2010 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022083s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022083s008ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/18/2018 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022083s026lbl.pdf
11/02/2016 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022083s023lbl.pdf
02/03/2015 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022083s020lbl.pdf
06/27/2013 SUPPL-19 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022083s019lbl.pdf
08/31/2012 SUPPL-16 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022083s016lbl.pdf
08/27/2010 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022083s008lbl.pdf
07/06/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022083lbl.pdf

EXELON

FILM, EXTENDED RELEASE;TRANSDERMAL; 4.6MG/24HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EXELON RIVASTIGMINE 4.6MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 022083 NOVARTIS
RIVASTIGMINE RIVASTIGMINE 4.6MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204403 ALVOGEN
RIVASTIGMINE RIVASTIGMINE 4.6MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 207308 AMNEAL PHARMS
RIVASTIGMINE RIVASTIGMINE 4.6MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 205622 MYLAN TECHNOLOGIES
RIVASTIGMINE RIVASTIGMINE 4.6MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 206318 ZYDUS NOVELTECH INC

FILM, EXTENDED RELEASE;TRANSDERMAL; 9.5MG/24HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EXELON RIVASTIGMINE 9.5MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 022083 NOVARTIS
RIVASTIGMINE RIVASTIGMINE 9.5MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204403 ALVOGEN
RIVASTIGMINE RIVASTIGMINE 9.5MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 207308 AMNEAL PHARMS
RIVASTIGMINE RIVASTIGMINE 9.5MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 205622 MYLAN TECHNOLOGIES
RIVASTIGMINE RIVASTIGMINE 9.5MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 206318 ZYDUS NOVELTECH INC

FILM, EXTENDED RELEASE;TRANSDERMAL; 13.3MG/24HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EXELON RIVASTIGMINE 13.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 022083 NOVARTIS
RIVASTIGMINE RIVASTIGMINE 13.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204403 ALVOGEN
RIVASTIGMINE RIVASTIGMINE 13.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 207308 AMNEAL PHARMS
RIVASTIGMINE RIVASTIGMINE 13.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 205622 MYLAN TECHNOLOGIES
RIVASTIGMINE RIVASTIGMINE 13.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 206318 ZYDUS NOVELTECH INC

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