Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090661
Company: JUBILANT CADISTA
Company: JUBILANT CADISTA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 500MG | 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 |
---|---|---|---|---|---|---|---|
12/15/2014 | 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-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
04/21/2021 | SUPPL-9 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
01/15/2021 | SUPPL-6 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
07/27/2016 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
11/13/2015 | SUPPL-2 | REMS-Proposal |
Label is not available on this site. |