Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090099
Company: AM REGENT
Company: AM REGENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FOSPHENYTOIN SODIUM | FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 05/13/2010 | 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 |
|---|---|---|---|---|---|
| 11/14/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/10/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |