Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021025
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EXELON | RIVASTIGMINE TARTRATE | EQ 2MG BASE/ML | SOLUTION;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 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20823ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-025_Exelon.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/18/2018 | SUPPL-24 | 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-23 | 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 | |
02/03/2015 | SUPPL-22 | Labeling, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020823s032,021025s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020823Orig1s032,021025Orig1s022ltr.pdf | |
10/01/2013 | SUPPL-20 | 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 | |
10/01/2013 | SUPPL-19 | 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-18 | 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 | |
06/27/2006 | SUPPL-8 | 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/2006/021025_s008_exelon_capsules.pdf | |
09/21/2004 | SUPPL-7 | 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-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823slr012,21025slr006ltr.pdf |
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 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021025_S003_EXELON_AP.pdf |
01/31/2001 | SUPPL-2 | Manufacturing (CMC)-Packaging |
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-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020823s036,021025s024lbl.pdf | |
11/02/2016 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020823s035,021025s023lbl.pdf | |
02/03/2015 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020823s032,021025s022lbl.pdf | |
02/03/2015 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020823s032,021025s022lbl.pdf | |
10/01/2013 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf | |
10/01/2013 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf | |
10/01/2013 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf | |
06/27/2006 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020823s016,021025s008lbl.pdf | |
04/21/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21025lbl.pdf |