Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020142
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CATAFLAM | DICLOFENAC POTASSIUM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CATAFLAM | DICLOFENAC POTASSIUM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 11/24/1993 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020142s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020142Orig1s029ltr.pdf | |
| 05/09/2016 | SUPPL-27 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020142s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020142Orig1s027ltr.pdf | |
| 11/24/2014 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/2011 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020142s021,s022ltr.pdf | |
| 02/23/2011 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020142s021,s022ltr.pdf | |
| 02/25/2009 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020142s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020142s019ltr.pdf | |
| 01/24/2006 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020142s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_019201s035ltr.pdf | |
| 09/19/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/2002 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1999 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/12/1997 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/20/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/28/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/06/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1995 | 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-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020142s029lbl.pdf | |
| 05/09/2016 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020142s027lbl.pdf | |
| 05/09/2016 | SUPPL-27 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020142s027lbl.pdf | |
| 05/09/2016 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020142s027lbl.pdf | |
| 02/23/2011 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf | |
| 02/23/2011 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf | |
| 02/25/2009 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020142s019lbl.pdf | |
| 01/24/2006 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020142s017lbl.pdf |