NDA 9395, held by Glenwood. Potassium Aminosalicylate.
As of Nov 13, 2026, NDA 9395 (Paskalium), held by Glenwood, was first approved by FDA on Nov 18, 1955, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 1955 | Original applicationNew active ingredient · Standard review | Approved | None posted |
| Paskalium1GM · tablet;oral | Potassium Aminosalicylate | Discontinued |
| Paskalium500MG · capsule;oral | Potassium Aminosalicylate | Discontinued |
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
