Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074846
Company: SHREE HARI INTL
Company: SHREE HARI INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETODOLAC | ETODOLAC | 400MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 02/28/1997 | 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-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/11/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/03/2000 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |