Thorazine

NDA 11120, held by Glaxosmithkline. Chlorpromazine Hydrochloride.

As of Nov 15, 2026, NDA 11120 (Thorazine), held by Glaxosmithkline, was first approved by FDA on Sep 18, 1957, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 18, 1957
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Sep 18, 1957	Original applicationNew dosage form · Standard review	Approved	None posted

Products

5 strengths and forms


Thorazine30MG · capsule, extended release;oral	Chlorpromazine Hydrochloride	Discontinued
Thorazine75MG · capsule, extended release;oral	Chlorpromazine Hydrochloride	Discontinued
Thorazine150MG · capsule, extended release;oral	Chlorpromazine Hydrochloride	Discontinued
Thorazine200MG · capsule, extended release;oral	Chlorpromazine Hydrochloride	Discontinued
Thorazine300MG · capsule, extended release;oral	Chlorpromazine Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Apr 3, 2001	Supplement 86Labeling · Standard review	Approved	Letter
Mar 27, 2000	Supplement 85Manufacturing · Standard review	Approved	None posted
Apr 22, 1998	Supplement 81Labeling · Standard review	Approved	None posted
Sep 20, 1996	Supplement 84Manufacturing · Standard review	Approved	None posted
Sep 18, 1957	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 11120
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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