Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214289
Company: TWI PHARMS
Company: TWI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYCOPHENOLATE SODIUM | MYCOPHENOLATE SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| MYCOPHENOLATE SODIUM | MYCOPHENOLATE SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 11/03/2021 | 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 |
|---|---|---|---|---|---|
| 08/13/2024 | SUPPL-7 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 01/31/2023 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |