Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019647
Company: UT SW MEDCTR
Company: UT SW MEDCTR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
POTASSIUM CITRATE | POTASSIUM CITRATE | 20MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION;ORAL | Discontinued | None | Yes | No |
POTASSIUM CITRATE | POTASSIUM CITRATE | 10MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
10/13/1988 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label is not available on this site. |