Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019201
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VOLTAREN | DICLOFENAC SODIUM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| VOLTAREN | DICLOFENAC SODIUM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| VOLTAREN | DICLOFENAC SODIUM | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/28/1988 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019201s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019201Orig1s048ltr.pdf | |
| 05/09/2016 | SUPPL-46 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019201s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019201Orig1s046ltr.pdf | |
| 06/05/2014 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/2013 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/2011 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019201s039,s040ltr.pdf | |
| 02/23/2011 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019201s039,s040ltr.pdf | |
| 02/25/2009 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019201s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019201s038ltr.pdf | |
| 07/09/2007 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019201s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019201s036ltr.pdf | |
| 01/24/2006 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019201s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_019201s035ltr.pdf | |
| 09/19/2002 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/2002 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/2001 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/2000 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/2000 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/2000 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1999 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/09/1999 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1997 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1997 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 04/20/1998 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/22/1995 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1995 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/02/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/2002 | SUPPL-18 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19201slr018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-201s018_Voltaren.cfm |
| 12/08/1994 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/04/1993 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1992 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/12/1990 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/27/1989 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/12/1991 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/30/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/06/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1989 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/20/1989 | SUPPL-1 | Manufacturing (CMC)-Control |
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-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019201s048lbl.pdf | |
| 05/09/2016 | SUPPL-46 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019201s046lbl.pdf | |
| 05/09/2016 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019201s046lbl.pdf | |
| 05/09/2016 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019201s046lbl.pdf | |
| 02/23/2011 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf | |
| 02/23/2011 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf | |
| 02/25/2009 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019201s038lbl.pdf | |
| 07/09/2007 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019201s036lbl.pdf | |
| 01/24/2006 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019201s035lbl.pdf |