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 |
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 |
|---|---|---|---|---|---|
| 05/08/2024 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022083s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022083Orig1s028ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 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 |
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 | SANDOZ |
| 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 | 209063 | BRECKENRIDGE |
| 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 PHARMS |
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 | SANDOZ |
| 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 | 209063 | BRECKENRIDGE |
| 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 PHARMS |
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 | SANDOZ |
| 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 | 209063 | BRECKENRIDGE |
| 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 PHARMS |