Drugs@FDA: FDA-Approved Drugs
Company: HERITAGE PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDOMETHACIN | INDOMETHACIN | 25MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/12/1986 | 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-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/23/2021 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/28/2008 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 11/16/2006 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/29/2002 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/12/2001 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/18/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/30/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/13/1987 | SUPPL-1 | Labeling |
Label is not available on this site. |