NDA 10571, held by Glaxosmithkline. Prochlorperazine Maleate.
As of Nov 13, 2026, NDA 10571 (Compazine), held by Glaxosmithkline, was first approved by FDA on Oct 23, 1956, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 1956 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| CompazineEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Prochlorperazine Maleate | DiscontinuedReference drug |
| CompazineEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Prochlorperazine Maleate | DiscontinuedReference drug |
| CompazineEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Prochlorperazine Maleate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 3, 2005 | Supplement 96Labeling · Standard review | Approved | |
| Apr 3, 2001 | Supplement 95Labeling · Standard review | Approved | |
| Sep 30, 1992 | Supplement 86Manufacturing · Priority review | Approved | None posted |
| Aug 21, 1979 | Supplement 58Labeling | Approved | None posted |
| Oct 23, 1956 | Original applicationNew molecular entity · Priority 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
