Drugs@FDA: FDA-Approved Drugs
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDOMETHACIN | INDOMETHACIN | 25MG | CAPSULE;ORAL | Discontinued | None | No | No |
| INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 04/20/1984 | ORIG-1 | Approval |
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-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018858s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018858Orig1s047ltr.pdf | |
| 07/19/2016 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-42 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018858Orig1s041,s042ltr.pdf | |
| 05/09/2016 | SUPPL-41 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018858Orig1s041,s042ltr.pdf | |
| 04/28/2008 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 06/07/2006 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 09/26/2002 | SUPPL-28 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/22/2002 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1996 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 10/05/1993 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/02/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 12/10/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 01/31/1990 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/22/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/26/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/12/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 09/24/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1985 | 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-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018858s047lbl.pdf | |
| 05/09/2016 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf | |
| 05/09/2016 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf | |
| 05/09/2016 | SUPPL-41 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf | |
| 05/09/2016 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf |