NDA 19647, held by Ut Sw Medctr. Potassium Citrate.
As of Nov 13, 2026, NDA 19647 (Potassium Citrate), held by Ut Sw Medctr, was first approved by FDA on Oct 13, 1988, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 13, 1988 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Potassium Citrate20MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · for solution;oral | Potassium Citrate | DiscontinuedReference drug |
| Potassium Citrate10MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · for solution;oral | Potassium Citrate | DiscontinuedReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
