Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201944
Company: TRIS PHARMA INC
Company: TRIS PHARMA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED 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 |
|---|---|---|---|---|---|---|---|
| 03/04/2016 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |