Drugs@FDA: FDA-Approved Drugs
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 09/04/1985 | 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-39 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/02/2021 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/02/2021 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-33 | Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/28/2008 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 06/27/2006 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 09/26/2002 | SUPPL-20 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/22/2002 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1996 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 10/05/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/02/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/10/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 01/31/1990 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/30/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/16/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/14/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/24/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1986 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/14/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1986 | SUPPL-2 | Labeling |
Label is not available on this site. |