NDA 11276, held by Glaxosmithkline. Prochlorperazine Edisylate.
As of Nov 14, 2026, NDA 11276 (Compazine), held by Glaxosmithkline, was not approved, with 1 approved supplement and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| CompazineEQ 10MG BASE/ML ยท concentrate;oral | Prochlorperazine Edisylate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 21, 1979 | Supplement 23Labeling | Approved | None posted |
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
