Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204210
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
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 |
---|---|---|---|---|---|---|---|
03/28/2016 | ORIG-1 | Approval |
Label is not available on this site. |