NDA 10742, held by Glaxosmithkline. Prochlorperazine Edisylate.
As of Nov 13, 2026, NDA 10742 (Compazine), held by Glaxosmithkline, was first approved by FDA on Apr 8, 1957, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 8, 1957 | Original applicationNew active ingredient · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| CompazineEQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Prochlorperazine Edisylate | DiscontinuedReference drug |
| Apr 3, 2001 | Supplement 65Labeling · Standard review | Approved | |
| Aug 21, 1979 | Supplement 31Labeling | Approved | None posted |
| Apr 8, 1957 | Original applicationNew active ingredient · Standard review | 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
