Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020254
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VOLTAREN-XR | DICLOFENAC SODIUM | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/08/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020254s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020254Orig1s030ltr.pdf | |
| 05/09/2016 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020254s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020254Orig1s028ltr.pdf | |
| 06/05/2014 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2014 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/2013 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/2011 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020254s019,s020ltr.pdf | |
| 02/23/2011 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020254s019,s020ltr.pdf | |
| 02/25/2009 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020254s018.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020254s018ltr.pdf | |
| 01/24/2006 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020254s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_019201s035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020254Orig1s016.pdf | |
| 09/19/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/2002 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/20/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1999 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/16/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/21/1996 | 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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020254s030lbl.pdf | |
| 05/09/2016 | SUPPL-28 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020254s028lbl.pdf | |
| 05/09/2016 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020254s028lbl.pdf | |
| 05/09/2016 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020254s028lbl.pdf | |
| 02/23/2011 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf | |
| 02/23/2011 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf | |
| 02/25/2009 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020254s018.pdf | |
| 01/24/2006 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020254s016lbl.pdf |