Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091248
Company: RK PHARMA
Company: RK PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYCOPHENOLATE SODIUM | MYCOPHENOLATE SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| MYCOPHENOLATE SODIUM | MYCOPHENOLATE SODIUM | EQ 180MG 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 |
|---|---|---|---|---|---|---|---|
| 01/08/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091248Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/13/2024 | SUPPL-20 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/11/2021 | SUPPL-17 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/21/2021 | SUPPL-15 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 01/15/2021 | SUPPL-14 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 11/13/2015 | SUPPL-3 | REMS-Modified |
Label is not available on this site. |