Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070674
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 04/29/1987 | 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 |
|---|---|---|---|---|---|
| 04/11/2024 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2021 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/12/2019 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/12/2019 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/15/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/01/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/29/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/01/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/24/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/02/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/03/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
INDOMETHACIN
CAPSULE;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 018829 | CHARTWELL MOLECULES |
| INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 070651 | CHARTWELL MOLECULES |
| INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 091276 | GLENMARK PHARMS LTD |
| INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 091240 | HETERO LABS LTD III |
| INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 070674 | SANDOZ |
| INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 090403 | ZYDUS LIFESCIENCES |