Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020823
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXELON | RIVASTIGMINE TARTRATE | EQ 1.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| EXELON | RIVASTIGMINE TARTRATE | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| EXELON | RIVASTIGMINE TARTRATE | EQ 4.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| EXELON | RIVASTIGMINE TARTRATE | EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 04/21/2000 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20823lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20823ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20823_Exelon.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/18/2018 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020823s036,021025s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021025Orig1s024, 020823Orig1s036ltr.pdf | |
| 11/02/2016 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020823s035,021025s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020823s035,021025s023,022083s023ltr.pdf | |
| 01/22/2016 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/2015 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020823s032,021025s022lbl.pdf | |
| 04/09/2014 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/2013 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/2013 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf | |
| 10/01/2013 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf | |
| 10/01/2013 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf | |
| 10/23/2006 | SUPPL-17 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/27/2006 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020823s016,021025s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020823s016, 021025s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020823_016_exelon.pdf | |
| 09/21/2004 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823s014,21025s007ltr.pdf |
| 05/05/2004 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823slr012,21025slr006ltr.pdf |
| 10/01/2013 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf | |
| 10/24/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/16/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/2002 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/2001 | SUPPL-3 | Labeling |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20823S3LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020823_S003_EXELON_AP.pdf | |
| 01/31/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/18/2018 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020823s036,021025s024lbl.pdf | |
| 11/02/2016 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020823s035,021025s023lbl.pdf | |
| 02/03/2015 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020823s032,021025s022lbl.pdf | |
| 10/01/2013 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf | |
| 10/01/2013 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf | |
| 10/01/2013 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf | |
| 10/01/2013 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf | |
| 06/27/2006 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020823s016,021025s008lbl.pdf | |
| 01/05/2001 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20823S3LBL.PDF | |
| 04/21/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20823lbl.pdf |