Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090111
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 250MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 12/22/2009 | 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 |
|---|---|---|---|---|---|
| 06/06/2023 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/06/2023 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/11/2021 | SUPPL-12 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/21/2021 | SUPPL-11 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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| 01/15/2021 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 07/27/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/13/2015 | SUPPL-8 | REMS-Proposal |
Label is not available on this site. |
||
| 09/27/2013 | SUPPL-7 | REMS-Modified |
Label is not available on this site. |
||
| 08/01/2012 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/25/2012 | SUPPL-4 | REMS-Proposal |
Label is not available on this site. |