Stelazine

NDA 11552, held by Glaxosmithkline. Trifluoperazine Hydrochloride.

As of Nov 13, 2026, NDA 11552 (Stelazine), held by Glaxosmithkline, was first approved by FDA on Apr 16, 1959, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 16, 1959
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Apr 16, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

6 strengths and forms


StelazineEQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Trifluoperazine Hydrochloride	DiscontinuedReference drug
StelazineEQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Trifluoperazine Hydrochloride	DiscontinuedReference drug
StelazineEQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Trifluoperazine Hydrochloride	DiscontinuedReference drug
StelazineEQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Trifluoperazine Hydrochloride	DiscontinuedReference drug
StelazineEQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Trifluoperazine Hydrochloride	DiscontinuedReference drug
StelazineEQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · concentrate;oral	Trifluoperazine Hydrochloride	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Oct 18, 2001	Supplement 113Manufacturing · Standard review	Approved	None posted
Apr 3, 2001	Supplement 112Labeling · Standard review	Approved	Review Letter
Oct 14, 1997	Supplement 111Manufacturing · Standard review	Approved	None posted
Aug 14, 1996	Supplement 110Manufacturing · Standard review	Approved	None posted
May 3, 1979	Supplement 71Labeling · Standard review	Approved	None posted
Apr 16, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 11552
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