Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070900
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Discontinued | None | No | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 02/09/1987 | 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 |
|---|---|---|---|---|---|
| 04/30/2021 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/13/2021 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/27/2006 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 09/10/2002 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/13/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/24/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |