Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210509
Company: AMNEAL
Company: AMNEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/02/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/12/2024 | SUPPL-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/07/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2022 | SUPPL-6 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 10/28/2022 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |