Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202720
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC 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 |
|---|---|---|---|---|---|---|---|
| 10/30/2014 | 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 |
|---|---|---|---|---|---|
| 08/11/2021 | SUPPL-9 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/21/2021 | SUPPL-8 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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| 01/15/2021 | SUPPL-7 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 11/21/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/13/2015 | SUPPL-1 | REMS-Proposal |
Label is not available on this site. |