NDA 9149, held by Glaxosmithkline. Chlorpromazine Hydrochloride, Chlorpromazine.
As of Nov 14, 2026, NDA 9149 (Thorazine), held by Glaxosmithkline, was first approved by FDA on Nov 20, 1957, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 1957 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Thorazine10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Chlorpromazine Hydrochloride | Discontinued |
| Thorazine25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Chlorpromazine Hydrochloride | Discontinued |
| Thorazine25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Chlorpromazine Hydrochloride | DiscontinuedReference drug |
| Thorazine50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Chlorpromazine Hydrochloride | Discontinued |
| Thorazine100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Chlorpromazine Hydrochloride | Discontinued |
| Thorazine200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Chlorpromazine Hydrochloride | Discontinued |
| Thorazine10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · syrup;oral | Chlorpromazine Hydrochloride | DiscontinuedReference drug |
| Thorazine25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · suppository;rectal | Chlorpromazine | DiscontinuedReference drug |
| Thorazine30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · concentrate;oral | Chlorpromazine Hydrochloride | DiscontinuedReference drug |
| Thorazine100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · suppository;rectal | Chlorpromazine | DiscontinuedReference drug |
| Thorazine100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · concentrate;oral | Chlorpromazine Hydrochloride | DiscontinuedReference drug |
| Apr 22, 1998 | Supplement 165Labeling · Priority review | Approved | None posted |
| Sep 20, 1996 | Supplement 178Manufacturing · Priority review | Approved | None posted |
| Aug 19, 1994 | Supplement 151Manufacturing · Priority review | Approved | None posted |
| Feb 14, 1992 | Supplement 173Manufacturing · Priority review | Approved | None posted |
| Nov 20, 1957 | 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
