Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022083
Company: SANDOZ
Company: SANDOZ
| 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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/08/2024 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022083s028lbl.pdf | |
| 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 |