Prolixin

NDA 12145, held by Apothecon. Fluphenazine Hydrochloride.

As of Nov 14, 2026, NDA 12145 (Prolixin), held by Apothecon, was first approved by FDA on Dec 23, 1959, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 23, 1959
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Dec 23, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prolixin2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · elixir;oral	Fluphenazine Hydrochloride	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 25Labeling	Approved	None posted
Dec 7, 2007	Supplement 24Labeling	Approved	None posted
Dec 7, 2007	Supplement 23Labeling	Approved	None posted
Dec 7, 2007	Supplement 22Labeling	Approved	None posted
Dec 7, 2007	Supplement 18Labeling	Approved	None posted
Dec 7, 2007	Supplement 17Labeling	Approved	None posted
Dec 7, 2007	Supplement 15Labeling	Approved	None posted
Dec 7, 2007	Supplement 14Labeling	Approved	None posted
Dec 7, 2007	Supplement 11Labeling	Approved	None posted
Dec 7, 2007	Supplement 7Labeling	Approved	None posted
Jul 12, 2002	Supplement 27Manufacturing · Standard review	Approved	None posted
Feb 6, 1979	Supplement 16Labeling	Approved	None posted
Dec 23, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 12145
Drugs@FDA: Overview at FDA
Company: Apothecon

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